| LIBERTY GLUCOSE CONTROL, MODEL 2120031 (K052980) | Liberty Healthcare Group, Inc. | 2005-11-30 |
| CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN (K051925) | Access Bio Incorporate | 2005-11-29 |
| ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK (K053059) | Roche Diagnostics | 2005-11-28 |
| SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY (K051114) | Sentinel Ch. Srl | 2005-11-25 |
| BE-CERTAIN PREGNANCY TEST (K051963) | Natureplex, LLC | 2005-11-23 |
| URYXXON 200 URINE ANALYZER (K051034) | Macherey-Nagel GmbH & Co. KG | 2005-11-22 |
| CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3; CLINIQA LINICAL BILIRUBIN CALIBRATION VERIFIERS LEVELS A-E (K052679) | Cliniqa Corporation | 2005-11-18 |
| SENTINEL UIBC LIQUID (K051111) | Sentinel Ch. Srl | 2005-11-17 |
| CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91 (K051757) | Diagnostic Chemicals , Ltd. | 2005-11-10 |
| TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET (K052148) | Reference Diagnostics, Inc. | 2005-11-09 |
| ABL80 FLEX ANALYZER (K051804) | Sendx Medical, Inc. | 2005-11-01 |
| ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET (K052982) | Roche Diagnostics | 2005-10-28 |
| AIMSTICK URINE REAGENT STRIPS (K051727) | Germaine Laboratories, Inc. | 2005-10-26 |
| SENTINEL CLIN CHEM CAL (K051452) | Sentinel Ch. Srl | 2005-10-25 |
| GEM PREMIER 3000 (K052121) | Instrumentation Laboratory CO | 2005-10-21 |
| TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013 (K051888) | Scantibodies Laboratory, Inc. | 2005-10-18 |
| ELECSYS PRECICONTROL BONE (K051543) | Roche Diagnostics Corp. | 2005-10-17 |
| AUTOCHECK6+ (K051928) | Radiometer Medical Aps | 2005-10-12 |
| ADVIA IMS GLUCOSE ASSAY (K052163) | Bayer Healthcare, LLC | 2005-10-11 |
| ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH (K051646) | Pointe Scientific, Inc., | 2005-10-07 |
| GLUCODR SUPERSENSOR SYSTEM (K050985) | All Medicus Co., Ltd. | 2005-10-07 |
| HBA1C LINEARITY SET (K052010) | Cone Bioproducts | 2005-10-04 |
| ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002 (K051514) | Hypoguard USA, Inc. | 2005-10-04 |
| ADVIA CHEMISTRY MICROALBUMIN CONTROLS (K052242) | Bayer Healthcare, LLC | 2005-10-03 |
| TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENALIN); NORADRENALIN RIA (K051969) | Ibl GmbH | 2005-10-03 |
| ISE COMPENSATOR (K052193) | Roche Diagnostics | 2005-10-03 |
| IBL CORTISOL LIA TEST KIT (K052359) | Lehnus & Associates Consulting | 2005-10-03 |
| OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200 (K052027) | Osmetech, Inc. | 2005-09-29 |
| DATA-TROL N NORMAL CONTROL SERUM, DATA-TROL A ABNORMAL CONTROL SERUM (K052056) | Thermo-Electron Corp. | 2005-09-23 |
| TRIAGE BNP TEST, MODEL 98000XR (K051787) | Biosite Incorporated | 2005-09-22 |
| WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014 (K051810) | Scantibodies Laboratory, Inc. | 2005-09-09 |
| STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK. (K051650) | Dade Behring, Inc. | 2005-09-08 |
| ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK (K051297) | Roche Diagnostics Corp. | 2005-09-08 |
| MODIFICATION TO ACCU-CHEK GO SYSTEM (K051592) | Roche Diagnostics Corp. | 2005-09-02 |
| CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108 (K052017) | Dade Behring, Inc. | 2005-09-01 |
| SENTINEL IRON LIQUID (K051115) | Sentinel Ch. Srl | 2005-08-25 |
| ULTRA HDL (K051962) | Abbott Laboratories | 2005-08-25 |
| ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL, ACCUCHEK INSTANT PLUS GLUCOCOSE (K051376) | Roche Diagnostics | 2005-08-23 |
| IRON STANDARD (K052002) | Roche Diagnostics Corp. | 2005-08-22 |
| WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST (K051841) | W.H.P.M., Inc. | 2005-08-22 |
| VANCOUVER BIOTECH HUMAN CARDIAC TROPONIN I IMMUNOASSAY TEST KIT (K050644) | Vancouver Biotech , Ltd. | 2005-08-17 |
| URITEK-720+ URINE ANALYZER (K051526) | Teco Diagnostics | 2005-08-16 |
| MODIFICATION TO ABL800 FLEX (K050869) | Radiometer Medical Aps | 2005-08-11 |
| FREESTYLE CONNECT BLOOD GLUCOSE MONITORING SYSTEM (K051802) | Abbott Diabetes Care, Inc. | 2005-08-09 |
| Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEM (K050182) | Biomedix, Inc. | 2005-08-09 |
| CLEVER CHECK TD-3215/DR. T TD-3216 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEMS (K051936) | Taidoc Technology Corporation | 2005-08-08 |
| DIRECT LDL CHOLESTEROL, MODEL L530-60H (K051121) | Teco Diagnostics | 2005-08-08 |
| CLEVER CHEK TD-4225, MODEL TD-4225 (K051854) | Taidoc Technology Corporation | 2005-08-05 |
| ABBOTT AXSYM B12 (K051327) | Abbott Laboratories | 2005-08-03 |
| GLUCOLAB BLOOD GLUCOSE MONITORING SYSTEM (K051285) | Infopia Co, Ltd. | 2005-08-02 |
| LIPOPROTEIN FOR MULTIPLE ANALYTES (K051619) | Bayer Healthcare, LLC | 2005-08-01 |
| DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR (K050823) | Teco Diagnostics | 2005-07-26 |
| TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT (K051150) | Scantibodies Laboratory, Inc. | 2005-07-26 |
| WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002 (K051141) | Scantibodies Laboratory, Inc. | 2005-07-26 |
| ELECSYS PRECICONTROL UNIVERSAL (K051687) | Roche Diagnostics Corp. | 2005-07-25 |
| SAFETY NEEDLE (K051019) | Sarstedt, Inc. | 2005-07-25 |
| SENTINEL PLASMAPROTEINS CAL 3X (K051457) | Sentinel Ch. Srl | 2005-07-25 |
| PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN A SALIVA-LIKE MATRIX AT A CONCENTRATION OF 2430 PG/ML. (K051012) | Salimetrics, LLC | 2005-07-19 |
| 3TEST GLUCOSE MONITORING SYSTEM (K050224) | Neuero Engineering, Inc. | 2005-07-13 |
| SIDEKICK BLOOD GLUCOSE TEST SYSTEM (K051147) | Home Diagnostics, Inc. | 2005-07-12 |
| MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT (K050960) | Wallac OY | 2005-07-11 |
| DIMENSION VISTA INTEGRATED SYSTEM (K051087) | Dade Behring, Inc. | 2005-07-11 |
| ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME) (K051752) | Roche Diagnostics | 2005-07-11 |
| PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM (K051108) | Abaxis, Inc. | 2005-07-08 |
| ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET (K050231) | Roche Diagnostics Corp. | 2005-07-06 |
| ELECSYS CA 19-9 CALCHECK (K051185) | Roche Diagnostics Corp. | 2005-07-06 |
| 1,25-DIHYDROXY VITAMIN D EIA (K051110) | Immunodiagnostic Systems , Ltd. | 2005-07-06 |
| JAUNDICE METER, MODEL JM 103 (K042522) | Draeger Medical Infant Care, Inc. | 2005-07-06 |
| ELECSYS PRECICONTROL ANEMIA (K051517) | Roche Diagnostics Corp. | 2005-07-05 |
| CREATININE LIQUICOLOR (K050283) | Stanbio Laboratory | 2005-06-30 |
| DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR (K050266) | Stanbio Laboratory | 2005-06-30 |
| FREESTYLE 600 BLOOD GLUCOSE MONITORING SYSTEM (K050500) | Abbott Diabetes Care, Inc. | 2005-06-27 |
| ELECSYS RBC FOLATE HEMOLYZED REAGENT (K051292) | Roche Diagnostics Corp. | 2005-06-17 |
| SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS (K051432) | Arkray, Inc. | 2005-06-17 |
| ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY (K051265) | Bayer Healthcare, LLC | 2005-06-13 |
| SPOTCHEM II LDH TEST (K050790) | Arkray, Inc. | 2005-06-06 |
| EZ SMART (K043340) | Vip Diagnostics, LLC | 2005-06-02 |
| NICHOLS ADVANTAGE ALDOSTERONE ASSAY (K050784) | Nichols Institute Diagnostics | 2005-06-01 |
| PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS (K051213) | Abbott Laboratories, Inc. | 2005-05-27 |
| ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY (K050632) | Bayer Healthcare, LLC | 2005-05-26 |
| ONE STEP HCG PREGNANCY URINE TEST FORMATS: STRIP, CASSETTE AND MIDSTREAM, MODELS BM-1-1, BM-1-2, BM-1-3, BM-2-1, BM-2-2 (K050305) | Bioscreen Medical, Inc. | 2005-05-23 |
| ACON +/- MIDSTREAM PREGNANCY TEST (K050546) | ACON Laboratories, Inc. | 2005-05-20 |
| ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM (K043197) | Lifescan, Inc. | 2005-05-20 |
| ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011 (K050748) | Scantibodies Laboratory, Inc. | 2005-05-20 |
| IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT (K050741) | Ind Diagnostic, Inc. | 2005-05-16 |
| IRMA TRUPOINT CREATININE CONTROL KIT (K050983) | International Technidyne Corporation | 2005-05-16 |
| RNA1C CONTROL FOR NYCOCARD HBA1C (K050961) | Bionostics, Inc. | 2005-05-13 |
| E.P.T. CERTAINTY PREGNANCY TEST (K050930) | Unipath , Ltd. | 2005-05-12 |
| ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX (K043218) | Radiometer Medical Aps | 2005-05-10 |
| URITEK 151 URINE ANALYZER, MODEL TC-151 (K042421) | Teco Diagnostics | 2005-05-09 |
| ORION DIAGNOSTICA UNIQ PINP RIA (K043125) | Orion Diagnostica, OY | 2005-05-04 |
| ACCU-CHEK INTEGRA SYSTEM (K050872) | Roche Diagnostics Corp. | 2005-05-02 |
| EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEM (K043245) | Eps Bio Technology Corp. | 2005-04-29 |
| ACCU-CHEK AVIVA SYSTEM (K043474) | Roche Diagnostics Corp. | 2005-04-27 |
| LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LIQUICHEK CARDIAC MARKERS PLUS (K050537) | Bio-Rad | 2005-04-27 |
| DATAPRO CLINICAL CHELISTRY ANALYZER (K042767) | Thermo Electron Corporation | 2005-04-27 |
| PROOF POSITIVE ELECTRONIC PREGNANCY TEST (K043231) | Mizuho USA, Inc. | 2005-04-25 |
| ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR (K050387) | Roche Diagnostics Corp. | 2005-04-25 |
| SAFEPICO (K043143) | Radiometer Medical Aps | 2005-04-22 |
| ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS (K043228) | Bayer Healthcare, LLC | 2005-04-22 |