| QUIDEL HOME PREGNANCY TEST (K981722) | Quidel Corp. | 1998-06-03 |
| BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30 (K981609) | Diagnostic Chemicals , Ltd. | 1998-06-03 |
| CREATININE (CREA) (K981240) | Abbott Laboratories | 1998-05-29 |
| ICON FXHCG URINE/SERUM TEST, ICON FXHCG URINE TEST, MODELS 40025,40050, 40005 & 41025 (K981512) | Skd, Inc. A Beckman Coulter Co. | 1998-05-28 |
| ACTIVE RENIN IRMA MODEL NUMBER DSL-25100 (K981607) | Diagnostic Systems Laboratories, Inc. | 1998-05-27 |
| ALBG (K981468) | Abbott Laboratories | 1998-05-27 |
| ALBP (K981457) | Abbott Mfg., Inc. | 1998-05-27 |
| ALKPHASE-B ASSAY KIT (K981373) | Metra Biosystems, Inc. | 1998-05-27 |
| STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK (K981099) | Dade Behring, Inc. | 1998-05-26 |
| ACCU-CHEK COMFORT CURVE TEST STRIPS (K980731) | Boehringer Mannheim Corp. | 1998-05-22 |
| COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL) (K974695) | Roche Diagnostic Systems, Inc. | 1998-05-21 |
| TIBC (K981279) | Abbott Laboratories | 1998-05-20 |
| ALKALINE PHOSPHATASE (ALKP) (K981245) | Abbott Laboratories | 1998-05-20 |
| BOEHRINGER MANNHEIM PRECINORM PRECIPATH PROTEIN CONTROLS (K981401) | Boehringer Mannheim Corp. | 1998-05-18 |
| CA (K981232) | Abbott Mfg., Inc. | 1998-05-18 |
| LD-1 (K981338) | Abbott Laboratories | 1998-05-18 |
| THIRD GENERATION PSA CONTROL MODULE (K981455) | Diagnostic Products Corp. | 1998-05-13 |
| LYPHOCHEK IMMUNOASSAY PLUS CONTROL (K981532) | Bio-Rad | 1998-05-12 |
| CO2 (K981231) | Abbott Mfg., Inc. | 1998-05-12 |
| URIC ACID (K981189) | Abbott Laboratories | 1998-05-07 |
| OLYMPUS SERUM PROTEIN MULTICALIBRATOR (K981305) | Olympus America, Inc. | 1998-05-07 |
| GLU (K981185) | Abbott Laboratories | 1998-05-07 |
| CARESIDE GLUCOSE (K981183) | Exigent Diagnostics, Inc. | 1998-05-07 |
| CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I) (K981474) | Spectral Diagnostics, Inc. | 1998-05-07 |
| IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES (K980646) | Instrumentation Laboratory CO | 1998-05-06 |
| REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL (K980650) | Helena Laboratories | 1998-05-01 |
| CREATINE KINASE (CK) (K981218) | Abbott Laboratories | 1998-05-01 |
| IRMA BLOOD ANALYSIS SYSTEM (K981270) | Diametrics Medical, Inc. | 1998-05-01 |
| TBIL (K981336) | Abbott Laboratories | 1998-05-01 |
| MG (K981192) | Abbott Laboratories | 1998-05-01 |
| N-ASSAY L D-BIL (K981276) | Crestat Diagnostics, Inc. | 1998-05-01 |
| IRON (K981241) | Abbott Laboratories | 1998-05-01 |
| IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5 (K980833) | Diagnostic Products Corp. | 1998-05-01 |
| QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE) (K973335) | Zenyx Scientific , Ltd. | 1998-04-30 |
| ABBOTT AXSYM 3RD GENERATION TSH ASSAY (K981060) | Abbott Laboratories | 1998-04-29 |
| STRATUS CS CARDIAC TROPONIN I TESTPAK (K981098) | Dade Behring, Inc. | 1998-04-27 |
| HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51 (K980772) | Diagnostic Chemicals , Ltd. | 1998-04-27 |
| N-ASSAY L T-BIL (K981289) | Crestat Diagnostics, Inc. | 1998-04-27 |
| ELECSYS CALCHECK FERRITIN (K981281) | Roche Diagnostics GmbH | 1998-04-24 |
| DIRECT BILIRUBIN (DBIL) (K981222) | Abbott Laboratories | 1998-04-24 |
| UREA (K981123) | Trace Scientific , Ltd. | 1998-04-24 |
| DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109 (K981436) | Casco Standards | 1998-04-24 |
| ASPARTATE AMINOTRANSFERASE (AST) (K981225) | Abbott Laboratories | 1998-04-23 |
| ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED) (K981221) | Abbott Laboratories | 1998-04-23 |
| ELECSYS CALCHECK CA 125II (K981278) | Roche Diagnostics GmbH | 1998-04-23 |
| ILAB 600 CLINICAL CHEMISTRY SYSTEM (K980757) | Instrumentation Laboratory CO | 1998-04-21 |
| PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES (K981035) | Sims Portex, Inc. | 1998-04-21 |
| INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401) (K980667) | Sigma Diagnostics, Inc. | 1998-04-21 |
| QUICKCHECK LYOPHILIZED CHEMISTRY CONTROL CONFORMANCE CHEMISTRY CONTROL C3 (K981339) | Consolidated Technologies, Inc. | 1998-04-21 |
| HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51 (K980770) | Diagnostic Chemicals , Ltd. | 1998-04-21 |
| AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST (K981165) | Germaine Laboratories, Inc. | 1998-04-16 |
| STRATUS CS CKMB CALPAK (K981097) | Dade Behring, Inc. | 1998-04-16 |
| STRATUS CS TROP CALPAK (K981100) | Dade Behring, Inc. | 1998-04-16 |
| UREA NITROGEN (BUN) LIQUID REAGENT (K981106) | Teco Diagnostics | 1998-04-16 |
| ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST (K980736) | Acon Laboratories Co. | 1998-04-16 |
| MACRALP(A) ENZYME IMMUNOASSAY KIT (K971157) | Strategic Diagnostics, Inc. | 1998-04-15 |
| UBAS MANUAL METHOD AND UBAS AUTOMATED METHOD (K980525) | Marukin Shoyu Co., Ltd. | 1998-04-15 |
| NOVA STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991) | Nova Biomedical Corp. | 1998-04-15 |
| STRATUS CS MYO CALPAK (K981101) | Dade Behring, Inc. | 1998-04-15 |
| MINISTRIP/ SERUM AND URINE COMBO HCG TEST (K974060) | International Newtech Development, Inc. | 1998-04-09 |
| ONE STEP MIDSTREAM HCG PREGNANCY TEST (K974059) | International Newtech Development, Inc. | 1998-04-09 |
| BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS (K980819) | Biocircuits Corp. | 1998-04-03 |
| QUICKCARD PRO HCG TEST, MODEL 9008 (K980896) | Phamatech | 1998-04-02 |
| AEROSET SYSTEM (K980367) | Abbott Laboratories | 1998-04-01 |
| CARESIDE CREATININE (K980043) | Exigent Diagnostics, Inc. | 1998-03-30 |
| N-ASSAY CPK-L (K980900) | Crestat Diagnostics, Inc. | 1998-03-26 |
| N-ASSAY L AST/GOT (K980902) | Crestat Diagnostics, Inc. | 1998-03-26 |
| AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR PACK MODEL NUMBER NUMBER 80601 AURAFLEX DIL0 (K980574) | Alfa Biotech (Uk) , Ltd. | 1998-03-24 |
| INFINITY AST REAGENT (PROCEDURE NO. 51) (K980666) | Sigma Diagnostics, Inc. | 1998-03-20 |
| TYROSINE 50-HOUR REAGENT KIT (K970093) | Astoria-Pacific, Inc. | 1998-03-19 |
| IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE (K980523) | Diametrics Medical, Inc. | 1998-03-19 |
| ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505 (K980173) | Beckman Instruments, Inc. | 1998-03-18 |
| PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG (K974009) | International Newtech Development, Inc. | 1998-03-13 |
| VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA (K973628) | Vital Scientific N.V. | 1998-03-13 |
| QUICKSTREAM ONE STEP PREGNANCY TEST MODEL NUMBER 9012 (K980532) | Phamatech | 1998-03-11 |
| CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30 (K973999) | Diagnostic Chemicals , Ltd. | 1998-03-11 |
| GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) (K980026) | Trace America, Inc. | 1998-03-10 |
| CARESIDE ANALYZER (K980056) | Exigent Diagnostics, Inc. | 1998-03-06 |
| AIMSTEP PREGNANCY (K980531) | Germaine Laboratories, Inc. | 1998-03-06 |
| RANDOX CREATININE (K973993) | Randox Laboratories, Ltd. | 1998-03-06 |
| OSTEOMARK (K980518) | Ostex Intl., Inc. | 1998-03-06 |
| CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVEL 1, MODEL AP11001, LEVEL 2, MODEL AP22002 (K980514) | Medical Analysis Systems, Inc. | 1998-03-04 |
| UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K974721) | Bayer Corp. | 1998-03-03 |
| CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI) (K980528) | Chiron Diagnostics Corp. | 1998-03-03 |
| VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET MODEL MULTIPLE, VACUTAINER BRAND BLOOD COLLECTION SET (K980414) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998-03-03 |
| TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50 (K973108) | Diagnostic Chemicals , Ltd. | 1998-03-02 |
| LIQUICHEK CARDIAC MARKERS CONTROL LT (K980556) | Bio-Rad | 1998-02-25 |
| CREATINE KINASE REAGENT (K980012) | Ac Biochemicals, Inc. | 1998-02-25 |
| VACUTAINER BRAND PPT PLASMA PREPARATION TUBE (K972075) | Becton Dickinson Vacutainer Systems | 1998-02-24 |
| TESTOTERONE ELISA (K973900) | Kmi Diagnostics, Inc. | 1998-02-24 |
| SYNERMED CREATININE REAGENT KIT (K974909) | Synermed Intl., Inc. | 1998-02-24 |
| AVL OPTI CRITICAL CARE ANALYZER (K974784) | Avl Scientific Corp. | 1998-02-24 |
| DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL (K972904) | Casco Standards | 1998-02-20 |
| CK-NAC REAGENT (K974833) | Intersect Systems, Inc. | 1998-02-13 |
| ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER (K974779) | Abbott Laboratories | 1998-02-13 |
| EPISCREEN ORAL SPECIMEN COLLECTION DEVICE (K973395) | Epitope, Inc. | 1998-02-13 |
| SAN DIEGO BIOTECH HCG PREGNANCY DIPSTICK TEST (K980205) | San Diego Biotech | 1998-02-12 |
| RANDOX MAGNESIUM (K974606) | Randox Laboratories, Ltd. | 1998-02-12 |
| OXYHEMOGLOBIN CONTROL FOR CO-OXIMETRY (K980178) | Bionostics, Inc. | 1998-02-12 |
| 2700 SAMPLE MANAGER (K980180) | Waters Corporation | 1998-02-12 |