| BIOSCANNER PLUS; LIPID PANEL TEST STRIPS (K013173) | Polymer Technology Systems, Inc. | 2001-10-22 |
| N LP(A) CONTROL SY (K013130) | Dade Behring, Inc. | 2001-10-18 |
| ACCESS UNCONJUGATED ESTRIOL CALIBRATORS (K012900) | Beckman Coulter, Inc. | 2001-10-16 |
| POLY STAT HCG TEST (K012559) | Bion Diagnostic Sciences | 2001-10-16 |
| MODIFICATION TO SYNCHRON CONTROL (K013235) | Beckman Coulter, Inc. | 2001-10-16 |
| THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609 (K012878) | Thermo Dma, Inc. | 2001-10-16 |
| RAICHEM GLUCOSE UV REAGENT (K012668) | Hemagen Diagnostics, Inc. | 2001-10-15 |
| RAICHEM BUN RATE REAGENT (K012649) | Hemagen Diagnostics, Inc. | 2001-10-15 |
| MODIFICATION TO ALPHA DX SYSTEM (K013118) | First Medical, Inc. | 2001-10-15 |
| UNIMARK HCG COMBO PREGNANCY TEST (K013194) | Biotech Atlantic, Inc. | 2001-10-10 |
| WIENER LAB. CREATININA CINETICA AA (K012065) | Wiener Laboratories Saic | 2001-10-10 |
| PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION CHEMISTRY SYSTEM (K012509) | Phoenix Diagnostics, Inc. | 2001-10-09 |
| PHEM-ALERT (K012230) | Femtek,Llc. | 2001-10-09 |
| TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113 (K012518) | Thermo Dma, Inc. | 2001-10-09 |
| VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D (K012367) | Nichols Institute Diagnostics | 2001-10-09 |
| ATAC PAK CPK REAGENT KIT (K012474) | Elan Holdings, Inc. | 2001-10-03 |
| BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC) (K012340) | Bayer Corp. | 2001-10-01 |
| RANDOX LIPOPROTEIN (K011568) | Randox Laboratories, Ltd. | 2001-09-28 |
| MODIFICATION TO N PROTEIN STANDARD SL (K012470) | Dade Behring, Inc. | 2001-09-28 |
| BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM (K011970) | Biosafe Laboratories, Inc. | 2001-09-26 |
| URISYS 2400 URINE TEST STRIP (K012397) | Roche Diagnostics Corp. | 2001-09-26 |
| VACUETTE EDTA K2 GEL TUBES (K012043) | Greiner Vacuette North America, Inc. | 2001-09-24 |
| RAICHEM MULTI-ANALYTE CALIBRATOR (K012250) | Hemagen Diagnostics, Inc. | 2001-09-24 |
| ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K (K010844) | Astoria-Pacific, Inc. | 2001-09-21 |
| WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300 (K012329) | Wiener Laboratories Saic | 2001-09-21 |
| WIENER LAB. UREA UV CINETICA AA (K012260) | Wiener Laboratories Saic | 2001-09-19 |
| DS30 HCY BLOOD COLLECTION TUBES (K012152) | Drew Scientific , Ltd. | 2001-09-18 |
| COLORMATE TLC BILITEST SYSTEM (K001687) | Chromatics Color Sciences Intl., Inc. | 2001-09-13 |
| EVENCARE BLOOD GLUCOSE MONITORING SYSTEM (K011240) | Medline Industries, Inc. | 2001-09-13 |
| GLUCOMETER DEX TEST SENSOR (K012205) | Bayer Corp. | 2001-09-12 |
| DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000 (K010973) | Hypoguard USA, Inc. | 2001-09-11 |
| STRATUS CS TROPONIN I CALIBRATOR (K012233) | Dade Behring, Inc. | 2001-09-11 |
| JAS CARBON DIOXIDE LIQUID REAGENT (K012332) | Jas Diagnostics, Inc. | 2001-09-06 |
| LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648 (K012656) | Bio-Rad | 2001-09-06 |
| NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT) (K011128) | Nichols Institute Diagnostics | 2001-09-06 |
| MODIFICATION TO N/T PROTEIN CONTROL SL (K012468) | Dade Behring, Inc. | 2001-09-04 |
| LIQUISPX LIQUID LIPID CONTROL (K012855) | Clinical Controls Division | 2001-08-30 |
| VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 (K012593) | Ortho-Clinical Diagnostics, Inc. | 2001-08-30 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS (K012561) | Ortho-Clinical Diagnostics | 2001-08-29 |
| LIQUICHEK LIPIDS CONTROL LEVEL 1, LIQUICHEK LIPIDS CONTROL LEVEL 2, MODELS 641 AND 642 (K012513) | Bio-Rad | 2001-08-29 |
| WH ACCU TEST PREGNANCY TEST (K012284) | W.H.P.M., Inc. | 2001-08-28 |
| COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3 (K012431) | Bionostics, Inc. | 2001-08-28 |
| MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3 (K012430) | Bionostics, Inc. | 2001-08-27 |
| DIRECT BILIRUBIN REAGENT (K011972) | Intersect Systems, Inc. | 2001-08-27 |
| MODIFICATION TO ELECSYS FSH II CALSET (K012399) | Roche Diagnostics Corp. | 2001-08-24 |
| QUIK-CHECK OVULATION PREDICTOR (K012252) | ACON Laboratories, Inc. | 2001-08-24 |
| JAS URIC ACID LIQUID REAGENT (K012038) | Jas Diagnostics, Inc. | 2001-08-21 |
| VALIDATE CHEM 2 CALIBRATION VERIFICATION TEST SET, MODEL 10002 (K012118) | Maine Standards Co. | 2001-08-20 |
| MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER (K012478) | I-Stat Corp. | 2001-08-20 |
| VALIDATE CHEM 3 CALIBRATION VERIFICATION TEST SET, MODEL 10003 (K012119) | Maine Standards Co. | 2001-08-20 |
| VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005 (K012122) | Maine Standards Co. | 2001-08-20 |
| MCC URICHECK ASSAYED LIQUID URINE MULTICONSTITUENT CONTROL (K012243) | Hematronix, Inc. | 2001-08-20 |
| VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004 (K012120) | Maine Standards Co. | 2001-08-20 |
| STAT PROFILE PHOX PLUS L ANALYZER (K012058) | Nova Biomedical Corp. | 2001-08-20 |
| VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001 (K012117) | Maine Standards Co. | 2001-08-20 |
| HCG STAT PAK ULTRA-FAST (K011550) | Chembio Diagnostic Systems, Inc. | 2001-08-14 |
| SURE CHECK PREGNANCY TEST (K011551) | Chembio Diagnostic Systems, Inc. | 2001-08-14 |
| QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD GLUCOSE STRIPS, QUICKTEK CONTROL SOLUTION (K010039) | Chronimed, Inc. | 2001-08-10 |
| GENZYME DIRECT-AMYLASE TEST REAGENT (K011843) | Genzyme Corp. | 2001-08-10 |
| MODIFICATION TO ACCU-CHEK INFORM METER (K012210) | Roche Diagnostics Corp. | 2001-08-09 |
| MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION (K012286) | Roche Diagnostics Corp. | 2001-08-08 |
| MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION (K012287) | Roche Diagnostics Corp. | 2001-08-07 |
| PRAXSYS RELIA TSH TEST (K011527) | Praxsys Biosystems, Inc. | 2001-08-07 |
| QUIK-CHECK HOME PREGNANCY TEST (K012215) | ACON Laboratories, Inc. | 2001-08-07 |
| WAKO IMMUNOASSAY CALIBRATOR SET (K010332) | Wako Chemicals USA, Inc. | 2001-08-01 |
| AUTOMATED WORKCELL CONTROL SOFTWARE (K010500) | Lab-Interlink, Inc. | 2001-08-01 |
| SUREVUE URINE HCG (K010522) | Sa Scientific, Inc. | 2001-07-31 |
| CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS (K011658) | Rochdiag | 2001-07-31 |
| GLUCOSE (HEXOKINASE) (K011900) | Jas Diagnostics, Inc. | 2001-07-31 |
| OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE (K011052) | Ostex Intl., Inc. | 2001-07-30 |
| LIPOPRINT SYSTEM, LDL SUBFRACTIONS (K010337) | Quantimetrix Corp. | 2001-07-25 |
| HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT (K011692) | Intersect Systems, Inc. | 2001-07-25 |
| HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT (K011689) | Catch, Inc. | 2001-07-25 |
| ALKALINE PHOSPHATASE LIQUID REAGENT (K011599) | Jas Diagnostics, Inc. | 2001-07-20 |
| UREA NITROGEN (BUN) LIQUID REAGENT (K011596) | Jas Diagnostic, Inc. | 2001-07-17 |
| ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10 (K011853) | Bio-Rad | 2001-07-17 |
| SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM) (K011525) | Biosafe Laboratories, Inc. | 2001-07-16 |
| LIQUID ASSAYED MULTIQUAL CONTROL LEVEL1 #981600; LEVEL 2 #981700; LEVEL 3 #981800 (K011867) | Bio-Rad | 2001-07-12 |
| TGL FLEX REAGENT CARTRIDGE (K010871) | Dade Behring, Inc. | 2001-07-09 |
| JAS CALCIUM (ARSENAZO) REAGENT (K011441) | Jas Diagnostics, Inc. | 2001-07-09 |
| TRI-POINT LIQUIMMUNE LIQUID ASSAYED CONTROL LEVELS 1,2, AND 3 (K011731) | Medical Analysis Systems, Inc. | 2001-07-05 |
| I-STAT SYSTEM (K011478) | I-Stat Corp. | 2001-07-02 |
| IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6 (K011505) | Diagnostic Products Corp. | 2001-07-02 |
| VACUETTE EVACUATED BLOOD COLLECTION TUBES (K011699) | Greiner Bio-One Vacuette North America | 2001-06-28 |
| LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580 (K011579) | Bio-Rad | 2001-06-26 |
| WAKO LIPID CALIBRATOR (K010334) | Wako Chemicals USA, Inc. | 2001-06-25 |
| OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER (K011720) | Olympus America, Inc. | 2001-06-25 |
| CALIBRATOR FOR AUTOMATED SYSTEMS (K011226) | Roche Diagnostics Corp. | 2001-06-25 |
| MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658 (K011145) | Roche Diagnostics Corp. | 2001-06-25 |
| INDUO BLOOD GLUCOSE METER (K011616) | Inverness Medical Innovations, Inc. | 2001-06-21 |
| BIOSCANNER CREATININE TEST STRIPS (K010456) | Polymer Technology Systems, Inc. | 2001-06-20 |
| ACCU-CHEK ACTIVE SYSTEM (K011738) | Roche Diagnostics Corp. | 2001-06-20 |
| PRECISION XTRA BLOOD GLUCOSE TEST STRIP WITH TRUEMEASURE TECHNOLOGY (K010553) | Abbott Laboratories | 2001-06-18 |
| CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVELS 1, 2, 3 (K011548) | Medical Analysis Systems, Inc. | 2001-06-18 |
| DIMENSION DRUG CALIBRATOR, MODEL DC22B (K011035) | Dade Behring, Inc. | 2001-06-14 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS (K011463) | Ortho-Clinical Diagnostics | 2001-06-13 |
| HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132) (K011113) | Sebia | 2001-06-13 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS (K011250) | Ortho-Clinical Diagnostics, Inc. | 2001-06-13 |
| LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1,2,3,1, ML, LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 3 ML, LIQUICHEK IMMUNOLOGY CONTROL (K011494) | Bio-Rad | 2001-06-08 |
| INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX (K011057) | OraSure Technologies, Inc. | 2001-06-06 |