| CIBA CORNING ACS ESTRADIOL-6 ASSAY (K954697) | Ciba Corning Diagnostics Corp. | 1995-12-13 |
| QUIX RAPID PREGNANCY STRIP TEST (K954993) | Guardian Scientific, Corp. | 1995-12-13 |
| BIONIKE A/Q PREGNANCY TEST (K954901) | Bionike Laboratories, Inc. | 1995-12-11 |
| AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) (K951494) | Emd Chemicals, Inc. | 1995-12-11 |
| HDL PRECIPITATING REAGENT (K954179) | Schiapparelli Biosystems, Inc. | 1995-12-11 |
| CAL 1 & CAL 2 SOLUTION, FLUSH SOLUTION KIT (K955154) | Alko Diagnostic Corp. | 1995-12-11 |
| OSOM HCG COMBO TEST (K955141) | Wyntek Diagnostics, Inc. | 1995-12-06 |
| ACCESS CORTISOL ASSAY (MODIFICATION) (K954733) | Bio-Rad Laboratories, Inc. | 1995-12-05 |
| ANTHOS 2010 READER (K955077) | Anthos Labtec, Inc. | 1995-12-04 |
| SENDX 100 PH, BLOOD GAS & ELECTROLYTE ANALYSIS SYSTEM (K954482) | Cirrus Medical,Inc. | 1995-12-04 |
| STAT PROFILE ULTRA 11 ANALYZER (MODIFICATION) (K954711) | Nova Biomedical Corp. | 1995-11-30 |
| COAT-A-COUNT DIRECT ANDROSTENEDIONE (K954755) | Diagnostic Products Corp. | 1995-11-29 |
| LIQUICHEK ETHANOL/AMMONIA CONTROL (K955024) | Bio-Rad | 1995-11-28 |
| VACUTAINER BRAND PST PLASMA SEPARATION TUBE (K954592) | Becton Dickinson Vacutainer Systems | 1995-11-28 |
| ALKALINE PHOSPHATASE REAGENT SYSTEM (K952746) | Medical Diagnostic Technologies, Inc. | 1995-11-27 |
| CHOLESTECH LDX SYSTEM (K954778) | Cholestech Corp. | 1995-11-24 |
| BIOCIRCUITS IOS (IN-OFFICE SYSTEM) (K952719) | Biocircuits Corp. | 1995-11-22 |
| ACCU-CHEK ALPHA MONITOR & ACCU-CHEK GLUCOSE TEST STRIPS (K952875) | Boehringer Mannheim Corp. | 1995-11-21 |
| GENESIS (K953345) | Tecan U.S., Inc. | 1995-11-21 |
| ACCESS HYPERSENSITIVE TSH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (K954825) | Bio-Rad Laboratories, Inc. | 1995-11-21 |
| ACCESS TOTAL BHCG ASSAY (MODIFICATION) (K954732) | Bio-Rad Laboratories, Inc. | 1995-11-20 |
| CALCITONIN IMMUNOASSAY KIT (K945961) | Nichols Institute Diagnostics | 1995-11-20 |
| MED-TECH CLINICAL BLOOD GAS (K953935) | Medical Technical Gases Inc.. | 1995-11-20 |
| BIOCIRCUITS IOS T4/TU TEST CARTRIDGES (K952751) | Biocircuits Corp. | 1995-11-20 |
| BIOCIRCUITS IOS T4 TEST CARTRIDGE (K953837) | Biocircuits Corp. | 1995-11-20 |
| ACCESS LOW LEVEL IGE CONTROLS (K953883) | Bio-Rad Laboratories, Inc. | 1995-11-14 |
| AURAFLEX TESTOSTERONE CALIBRATOR PACK (K951685) | Organon Teknika Corp. | 1995-11-14 |
| BOEHRINGER MANNHEIM CARDIAC T TROPONIN T RAPID ASSAY (K952478) | Boehringer Mannheim Corp. | 1995-11-09 |
| IMMUCHEM GAL-MW EA (K951329) | Icn Pharmaceuticals, Inc. | 1995-11-09 |
| ABL SYSTEM 625, 615, 605 (K954612) | Radiometer America, Inc. | 1995-11-09 |
| MAS LIQUID URINALYSIS CONTROL (K954323) | Medical Analysis Systems, Inc. | 1995-11-09 |
| FIRST CHOICE(TM) TEST STRIP (K946166) | Polymer Technology Intl. | 1995-11-08 |
| FIRST CHOICE TEST STRIP (K950628) | Polymer Technology Intl. | 1995-11-08 |
| INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION) (K954418) | Nichols Institute Diagnostics | 1995-11-03 |
| PYRILINKS ASSAY KIT (K952506) | Metra Biosystems, Inc. | 1995-11-03 |
| PYRILINKS POLYCLONAL ASSAY KIT (K952026) | Metra Biosystems, Inc. | 1995-11-03 |
| FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE ANALYSIS SYSTEM (K945519) | Pharmaquest Corp. | 1995-11-03 |
| VIROTROL IV (K954298) | Blackhawk Biosystems, Inc. | 1995-11-01 |
| CHEMSTRIP MICRAL URINE TEST STRIPS (K954346) | Boehringer Mannheim Corp. | 1995-10-26 |
| ELX808 AUTOMATED MICROPLATE READERS (K953710) | Bio-Tek Instruments, Inc. | 1995-10-25 |
| ROCHE REAGENT FOR BUN (K954000) | Roche Diagnostic Systems, Inc. | 1995-10-25 |
| TRIGLYCERIDES REAGENT (K954187) | Schiapparelli Biosystems, Inc. | 1995-10-23 |
| CHEMSTRIP CRITERION URINE ANALYZER (K954024) | Boehringer Mannheim Corp. | 1995-10-23 |
| OSOM PREGNANCY TEST (K954178) | Wyntek Diagnostics, Inc. | 1995-10-23 |
| PH-DETECT TEST (K952178) | Diagnostic Reagents, Inc. | 1995-10-20 |
| ACCESS PROLACTIN ASSAY (MODIFICATION) (K954680) | Bio-Rad Laboratories, Inc. | 1995-10-20 |
| BUHLMANN ANGIOSTENSIN II RIA (K954299) | Buhlmann Laboratories AG | 1995-10-19 |
| ELX800UV (K953572) | Bio-Tek Instruments, Inc. | 1995-10-19 |
| MEDTEC AUTOBLOT 2000 (K951753) | Medtec, Inc. | 1995-10-17 |
| EML105 ELECTROLYTE METABOLITE ANALYZER (K952621) | Radiometer America, Inc. | 1995-10-17 |
| CARDS Q.S. HCG OR CONCISE PERFORMANCE PLUS HCG (K954273) | Quidel Corp. | 1995-10-16 |
| TRACE COBAS MIRA RANGE (K952488) | Trace Scientific , Ltd. | 1995-10-13 |
| STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY (K954266) | Solarcare Technologies Corp,Inc. | 1995-10-13 |
| CAMEO HOME PREGNANCY TEST (K954364) | Quidel Corp. | 1995-10-13 |
| ACTIVE THYROXINE RIA (K954312) | Diagnostic Systems Laboratories, Inc. | 1995-10-07 |
| AALTO SCIENTIFIC LIQUID CARDIAC CONTROL (K954074) | Aalto Scientific, Ltd. | 1995-10-07 |
| OPUS HCG CONTROLS (K954144) | Behring Diagnostics, Inc. | 1995-10-06 |
| WAKO AUTOKIT GLUCOSE (K950172) | Wako Chemicals USA, Inc. | 1995-10-05 |
| TESTPACK PLUS HCG URINE (K954029) | Abbott Laboratories | 1995-10-05 |
| CARBON DIOXIDE - DST (K952410) | Trace America, Inc. | 1995-10-05 |
| APOLIPOPROTEIN CALIBRATOR (APO-CAL) (K953979) | Beckman Instruments, Inc. | 1995-10-03 |
| FIRST RESPONSE OVULATION PREDICTOR TEST (K953581) | Armkel, LLC | 1995-10-03 |
| MINISTRIP HCG (K951705) | International Newtech Development, Inc. | 1995-10-03 |
| DMA GLUCOSE HEXOKINASE U.V. PROCEDURE (K952437) | Data Medical Associates, Inc. | 1995-10-03 |
| ABBOTT IMX PROLACTIN(MODIFICATION) (K953656) | Abbott Mfg., Inc. | 1995-10-03 |
| ULTRA-SENSITIVE ESTRADIOL (K953605) | Diagnostic Systems Laboratories, Inc. | 1995-10-02 |
| ASPARTATE AMINOTRANSFERASE REAGENT SYSTEM (K952743) | Medical Diagnostic Technologies, Inc. | 1995-09-29 |
| BILI-METER (K953005) | Olympic Medical Corp. | 1995-09-28 |
| SEDITAINER* ERYTHROCYTE SEDIMENTATION RATE (ESR) SYSTEM (K953994) | Becton Dickinson Vacutainer Systems | 1995-09-26 |
| HEMA-TROL Q-CHECK (K952385) | Medical Specialties Intl., Inc. | 1995-09-25 |
| BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER (K953239) | Boehringer Mannheim Corp. | 1995-09-25 |
| ACCESS ULTRASENSITIVE INSULIN ASSAY (K953084) | Bio-Rad Laboratories, Inc. | 1995-09-25 |
| ABBOTT AXSYM PROLACTIN(MODIFICATION) (K953657) | Abbott Mfg., Inc. | 1995-09-25 |
| ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE (K950803) | Isolab, Inc. | 1995-09-21 |
| CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE PHOSPHOKINASE-N-ACETYL-L-CYSTEINE (K952427) | Beckman Instruments, Inc. | 1995-09-21 |
| VACUTAINER PLUS TUBES (K953463) | Becton Dickinson Vacutainer Systems | 1995-09-20 |
| IRON/TIBC REAGENT (K935712) | Horizon Diagnostics, Inc. | 1995-09-20 |
| ROCHE CALIBRATOR SERUM (K942706) | Roche Diagnostic Systems, Inc. | 1995-09-20 |
| APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT (K950383) | Randox Laboratories, Ltd. | 1995-09-15 |
| PRENVAL I (K953652) | Base Ten Systems, Inc. | 1995-09-15 |
| APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KIT (K950382) | Randox Laboratories, Ltd. | 1995-09-15 |
| ROCHE AMMONIA/ETHANOL/CO2 CALIBRATOR (K952282) | Roche Diagnostic Systems, Inc. | 1995-09-15 |
| ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES (K951595) | Roche Diagnostic Systems, Inc. | 1995-09-08 |
| IMMULITE HCG HIGH LEVEL CONTROL MODULE (K952251) | Diagnostic Products Corp. | 1995-09-08 |
| WAKO AUTOKIT APO A1 (K952615) | Wako Chemicals USA, Inc. | 1995-09-08 |
| HICHEM ISE DILUENT KIT 70008 (K953860) | Hichem Diagnostics | 1995-09-06 |
| URINARY METANEPHRINE KIT (K952919) | Bioanalytical Systems, Inc. | 1995-09-06 |
| GLUCOSE TEST ITEM NUMBER 97375/94 (K951750) | Emd Chemicals, Inc. | 1995-09-06 |
| HICHEM ISE INTDERNAL REFERENCE KIT 70009 (K953861) | Hichem Diagnostics | 1995-09-06 |
| HICHEM ISE STANDARDS KIT 70011 (K953863) | Hichem Diagnostics | 1995-09-06 |
| HICHEM ISEKCI SOLUTION KIT 70010 (K953862) | Hichem Diagnostics | 1995-09-06 |
| ELSA-HCT (K951708) | Cis-Us, Inc. | 1995-09-05 |
| QUALICHECK 4 GLUCOSE (K952637) | Radiometer America, Inc. | 1995-09-05 |
| FLUOROSCAN NEONATAL (K950415) | Isolab, Inc. | 1995-09-05 |
| BIOSCAN (K952307) | Biosys Laboratories, Inc. | 1995-09-05 |
| DUPONT LIPASE CALIBRATOR (K952815) | Dupont Medical Products | 1995-08-31 |
| SYNERMED CALCIUM REAGENT KIT (K953395) | Synermed, Inc. | 1995-08-31 |
| WYNTEK OSOM HCG-URINE TEST (K953383) | Wyntek Diagnostics, Inc. | 1995-08-29 |
| OPUS T3 (K953160) | Behring Diagnostics, Inc. | 1995-08-24 |
| CSF LIQUID CEREBROSPINAL FLUID CONTROL (K952877) | Medical Analysis Systems, Inc. | 1995-08-24 |