| DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE (K061020) | Dade Behring, Inc. | 2006-05-10 |
| GLUCOSE (K060383) | Abbott Laboratories | 2006-05-05 |
| CARBON DIOXIDE (K060295) | Abbott Laboratories | 2006-05-04 |
| ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH (K060585) | Roche Diagnostics Corp. | 2006-05-03 |
| TOTAL BILIRUBIN (K060574) | Abbott Laboratories | 2006-05-03 |
| NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS (K060345) | Nova Biomedical Corp. | 2006-04-28 |
| SYNCHRON SYSTEMS CREATININE (CREA) REAGENT (K060935) | Beckman Coulter, Inc. | 2006-04-28 |
| IMMULITE 2500 VITAMIN B12 MODEL L5KVB2-200 TEST,L5KVB6-600 TEST, IMMULITE 2500 FOLIC ACID MODEL L5KFO2-200 TEST,L5KFO6-6 (K060929) | Diagnostic Products Corporation | 2006-04-28 |
| LIBERTY NORMAL GLUCOSE CONTROL SOLUTION (K060706) | Liberty Healthcare Group, Inc. | 2006-04-28 |
| DRI-STAT ACID PHOSPHATASE REAGENT (K053612) | Beckman Coulter, Inc. | 2006-04-26 |
| CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250 (K060140) | Diagnostic Chemicals , Ltd. | 2006-04-24 |
| VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 99, VITROS CHEMISTRY PRODUCTS AAT/HPT PERFORMANCE VERIFIER I, II, AND III (K060940) | Ortho-Clinical Diagnostics, Inc. | 2006-04-24 |
| FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208 (K060774) | Beckman Coulter, Inc. | 2006-04-21 |
| PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS (K060768) | Abbott Diabetes Care, Inc. | 2006-04-21 |
| ELECSYS TSH CALSET W/MODELS 04738551 (K060754) | Roche Diagnostics Corp. | 2006-04-18 |
| G4, MODEL IGM-0004 (K051651) | U. S. Diagnostics, Inc. | 2006-04-14 |
| DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE DILUENT (K053577) | Dade Behring, Inc. | 2006-04-14 |
| ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10 (K060359) | Denka Seiken Co., Ltd. | 2006-04-14 |
| HEMOGLOBIN ALC CONTROL (K060570) | Compass Bioscience | 2006-04-13 |
| ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; ASCENSIA MICROFILL REAGENT STRIP, MODEL 7080 (K060470) | Bayer Healthcare | 2006-04-12 |
| ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK (K060755) | Roche Diagnostics Corp. | 2006-04-10 |
| DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR (K060628) | Dade Behring, Inc. | 2006-04-06 |
| OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS (K050988) | Lin-Zhi International, Inc. | 2006-04-06 |
| STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAK (K060548) | Dade Behring, Inc. | 2006-04-06 |
| EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT (K060385) | Dade Behring, Inc. | 2006-04-06 |
| PTS PANELS HDL CHOLESTEROL TEST STRIPS (K060617) | Polymer Technology Systems, Inc. | 2006-04-05 |
| RX IMOLA (K052914) | Randox Laboratories, Ltd. | 2006-03-31 |
| ETI-MAX 3000 (K052794) | DiaSorin, Inc. | 2006-03-31 |
| N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H (K052788) | Dade Behring, Inc. | 2006-03-29 |
| CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS (K052525) | DFI Co., Ltd. | 2006-03-29 |
| ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001 (K053079) | Hypoguard USA, Inc. | 2006-03-28 |
| TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM (K060120) | Teco Diagnostics | 2006-03-27 |
| ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002 (K060215) | Eurotrol B.V. | 2006-03-24 |
| SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS (K053401) | Arkray, Inc. | 2006-03-24 |
| CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED (K060322) | Cliniqa Corporation | 2006-03-21 |
| MISSION COMPLETE (K060206) | Diamond Diagnostics, Inc. | 2006-03-21 |
| TDM CONTROL SET (K060429) | Roche Diagnostics Corp. | 2006-03-15 |
| STATUSFIRST CHF (CONGESTIVE HEART FAILURE) NT-PROBNP, MODEL 20204 (K051596) | Nanogen, Inc. | 2006-03-13 |
| FERRITIN CALIBRATOR SET, CATALOG NO. 8203 (K053291) | Reference Diagnostics, Inc. | 2006-03-13 |
| COBAS 6000 SERIES SYSTEM (K060373) | Roche Diagnostics | 2006-03-13 |
| FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 11001 (K051839) | Abbott Diabetes Care, Inc. | 2006-03-09 |
| THE EMIT 2000 TACROLIMUS CALIBRATORS (K060371) | Dade Behring, Inc. | 2006-03-09 |
| LIBERTY GLUCOSE CONTROL SOLUTION (K060481) | Liberty Healthcare Group, Inc. | 2006-03-09 |
| ACCUREX GLUCOSE TEST STRIP (K052207) | Incline Medical, LLC | 2006-03-09 |
| DIMENSION IRON CALIBRATOR (K060266) | Dade Behring, Inc. | 2006-03-09 |
| LIBERTY GLUCOSE NORMAL CONTROL SOLUTIONS, MODEL 2120041 (K060426) | Liberty Healthcare Group, Inc. | 2006-03-09 |
| DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85) (K060264) | Dade Behring, Inc. | 2006-03-08 |
| DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR (K053531) | Dade Behring, Inc. | 2006-03-03 |
| NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN (K050975) | Nano-Ditech Co. | 2006-03-02 |
| MYSET PREGNANCY TEST (K053138) | Ani Biotech OY | 2006-03-01 |
| EASYMATE BLOOD GLUCOSE MONITORING SYSTEM (K053312) | Bioptik Technology, Inc. | 2006-03-01 |
| MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002 (K060420) | Scantibodies Laboratory, Inc. | 2006-03-01 |
| UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM (K060256) | Beckman Coulter, Inc. | 2006-02-27 |
| MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT (K060348) | Scantibodies Laboratory, Inc. | 2006-02-27 |
| DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT CARTRIDGE (K060090) | Dade Behring, Inc. | 2006-02-27 |
| MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM (K053635) | Bionime Corporation | 2006-02-21 |
| ARTON ONE-STEP HCG URINARY PREGNANCY TEST (STRIP), (CASSETTE), (MIDSTREAM) (K060019) | Artron Laboratories, Inc. | 2006-02-17 |
| HEMOCUE ALBUMIN 201 ANALYZING SYSTEM (K053253) | Hemocue AB | 2006-02-17 |
| COBAS INTEGRA CHLORIDE ELCTRODE GEN.2 (K060108) | Roche Diagnostics Corp. | 2006-02-16 |
| ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET (K060133) | Inverness Medical Innovations, Inc. | 2006-02-16 |
| MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A (K053566) | Diazyme Laboratories | 2006-02-15 |
| DIMENSION VISTA MYO REAGENT CARTRIDGE AND CALIBRATOR (K053576) | Dade Behring, Inc. | 2006-02-07 |
| EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (K053061) | Dade Behring, Inc. | 2006-02-06 |
| IMMULITE/IMMULITE 1000 TURBO INTACT PTH (K053533) | Diagnostic Products Corporation | 2006-02-03 |
| SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS (K051648) | Arkray, Inc. | 2006-01-31 |
| DRG SLV TESTOSTERONE ELISA TEST (K052649) | Drg Intl., Inc. | 2006-01-27 |
| SENTINEL PANCREATIC AMYLASE (K051447) | Sentinel Ch. Srl | 2006-01-26 |
| OXICOM CONTROL (K053327) | Bionostics, Inc. | 2006-01-26 |
| ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH) (K060027) | Biokit, S.A. | 2006-01-26 |
| LIFESIGN DXPRESS, MODEL LSR2000 (K050955) | Princeton BioMeditech Corp. | 2006-01-23 |
| TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200 (K052789) | Biosite Incorporated | 2006-01-23 |
| LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067 (K052762) | Agamatrix, Inc. | 2006-01-23 |
| ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM (K053529) | Lifescan, Inc. | 2006-01-17 |
| VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET (K053247) | Maine Standards Co. | 2006-01-13 |
| RANDOX CALIBRATION SERUM (K053153) | Randox Laboratories, Ltd. | 2006-01-13 |
| Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge (K053110) | I-Stat Corporation | 2006-01-13 |
| FASTPACK TSH IMMUNOASSAY (K052301) | Qualigen, Inc. | 2006-01-04 |
| SMARTPREP2 CENTRIFUGE SYSTEM (K052925) | Harvest Technologies, Corp. | 2006-01-04 |
| WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791 (K053132) | Wako Chemicals USA, Inc. | 2005-12-30 |
| TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM (K053020) | Bayer Healthcare, LLC | 2005-12-30 |
| WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191 (K053131) | Wako Chemicals USA, Inc. | 2005-12-30 |
| DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR (K053104) | Dade Behring, Inc. | 2005-12-23 |
| VITROS CHEMISTRY PRODUCTS DTIBC REAGENT (K052867) | Ortho-Clinical Diagnostics, Inc. | 2005-12-23 |
| ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES. (K052694) | Ind Diagnostic, Inc. | 2005-12-16 |
| ARCHITECT B12 CALIBRATORS (K053330) | Abbott Laboratories | 2005-12-16 |
| ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE) (K052007) | Horiba Abx | 2005-12-16 |
| ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) (K053196) | Inverness Medical Innovations, Inc. | 2005-12-16 |
| DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR (K053090) | Beckman Coulter, Inc. | 2005-12-16 |
| I-STAT CREATINE KINASE MB (CK-MB) (K051433) | I-Stat Corporation | 2005-12-15 |
| ISE INDIRECT NA, K, CL FOR GEN.2 (K053165) | Roche Diagnostics Corp. | 2005-12-14 |
| TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM (K052503) | Bayer Healthcare, LLC | 2005-12-14 |
| TECO ISE REAGENT SET FOR CX SYSTEM (K052724) | Teco Diagnostics | 2005-12-14 |
| GLUCOSE PILOT (K052208) | Tianjin New Bay Bioresearch Co., Ltd. | 2005-12-09 |
| AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A (K053157) | Dade Behring, Inc. | 2005-12-09 |
| SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100 (K052108) | Sein Electronics Co., Ltd. | 2005-12-07 |
| TOTAL BILE ACIDS ASSAY, MODEL DZ042A (K051714) | Diazyme Laboratories | 2005-12-07 |
| ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL (K051733) | Drg Intl., Inc. | 2005-12-07 |
| E-SAN BLUETOOTH CRADLE (K052343) | E-San Limited | 2005-12-07 |
| ELECSYS PROBNP IMMUNOASSAY (K051382) | Roche Diagnostics Corp. | 2005-12-05 |
| ONE STEP FSH MENOPAUSAL TEST (K052662) | Ind Diagnostic, Inc. | 2005-11-30 |