| ASPARTATE AMINOTRANSFERASE-SL ASSAY, CATALOGUE NUMBER 319-10, 319-30 (K974001) | Diagnostic Chemicals , Ltd. | 1997-11-13 |
| ELECSYS FOLATE (K973674) | Boehringer Mannheim Corp. | 1997-11-12 |
| ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (K974075) | Beckman Instruments, Inc. | 1997-11-10 |
| DADE TRU-LIQUID CARDIAC CONTROL (K973974) | Dade Intl., Inc. | 1997-11-06 |
| Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30 (K974000) | Diagnostic Chemicals , Ltd. | 1997-11-04 |
| OSOM CARD HCG-URINE TEST (K973879) | Wyntek Diagnostics, Inc. | 1997-11-04 |
| SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30 (K973933) | Diagnostic Chemicals , Ltd. | 1997-11-04 |
| ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (K973743) | Beckman Instruments, Inc. | 1997-10-31 |
| ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (K973966) | Beckman Instruments, Inc. | 1997-10-31 |
| ACTIVE INTACT PTH (K973514) | Diagnostic Systems Laboratories, Inc. | 1997-10-31 |
| QUICK CARD HCG ONE STEP PREGNANCY TEST (K973570) | Phamatech | 1997-10-31 |
| DUET GLUCOSE CONTROL MONITORING SYSTEM (K973140) | Lxn Corp. | 1997-10-31 |
| IMMUSURE (K973894) | Quantimetrix Corp. | 1997-10-29 |
| MATRIX PLUS MULTI-CALIBRATOR KIT (K973345) | Verichem Laboratories, Inc. | 1997-10-29 |
| HYDRAGEL 7,15,30, CHOL-HDL KIT (K972015) | Morax | 1997-10-27 |
| OPUS HLH CONTROLS (K973832) | Behring Diagnostics, Inc. | 1997-10-27 |
| SPIFE (K972274) | Helena Laboratories | 1997-10-27 |
| BRAND NAME *1-STEP PREGNANCY (K973352) | Armkel, LLC | 1997-10-27 |
| TBD* ONE-STEP OVULATION PREDICTOR TEST (K973310) | Armkel, LLC | 1997-10-27 |
| LIQUID ALKALINE PHOSHATASE REAGENT SET (K973588) | Pointe Scientific, Inc., | 1997-10-22 |
| FIRST SIGN (K973208) | Texas Immunology, Inc. | 1997-10-20 |
| TROPONIN (TROP) METHOD (K973650) | Dade Chemistry Systems, Inc. | 1997-10-20 |
| I-STAT SYSTEM (K973292) | I-Stat Corp. | 1997-10-20 |
| DBEST REAGENT STRIP FOR URINALYSIS (K973142) | Ameritek, Inc. | 1997-10-20 |
| CARDIAC TROPONIN-I (TROP) CALIBRATOR (K973668) | Dade Intl., Inc. | 1997-10-20 |
| ABC LINEARITY VERIFIERS (K973790) | Sc Calibrators & Controls, LLC | 1997-10-14 |
| ABC CALIBRATION VERIFIERS (K973791) | Sc Calibrators & Controls, LLC | 1997-10-14 |
| LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET (K973157) | Pointe Scientific, Inc., | 1997-10-10 |
| MAGO AUTOMATED EIA PROCESSOR (K973177) | Diamedix Corp. | 1997-10-09 |
| GLUCOTREND BASIC SYSTEM (K972876) | Boehringer Mannheim Corp. | 1997-10-09 |
| LIQUID LDH-L REAGENT SET (K973589) | Pointe Scientific, Inc., | 1997-10-08 |
| ACCURUN 140 RUBELLA IGG POSITIVE CONTROL (K972986) | Boston Biomedica, Inc. | 1997-10-08 |
| PRECINORM RF, PRECIPATH RF (K973629) | Boehringer Mannheim Corp. | 1997-10-07 |
| TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN, TRIAGE TROPONIN-I AND CK-MB, TRIAGE TROPONIN-I (K973126) | Biosite Incorporated | 1997-10-06 |
| ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM (K973367) | Radiometer America, Inc. | 1997-10-06 |
| 2487 DUAL WAVELENGTH ABSORBANCE DETECTOR (K973074) | Waters Corporation | 1997-10-06 |
| ACCUWELL T4-EIA (K972974) | Neometrics, Inc. | 1997-10-06 |
| MYOGLOBIN CONTROL SET (K973358) | Boehringer Mannheim Corp. | 1997-10-06 |
| REP SPE VIS-60/40 KIT (K973316) | Helena Laboratories | 1997-10-01 |
| PROSTATE SPECIFIC ANTIGEN CONTROL (K973099) | Dade Chemistry Systems, Inc. | 1997-09-29 |
| PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR (K973100) | Dade Chemistry Systems, Inc. | 1997-09-29 |
| MAS LIQUID URINALYSIS CONTROL LEVEL 1, LEVEL 2 AND LEVEL 3 (K973451) | Medical Analysis Systems, Inc. | 1997-09-29 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS (K973517) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-09-25 |
| WAKO CH50 LINEARITY SET (K973055) | Wako Chemicals USA, Inc. | 1997-09-25 |
| SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT (K973109) | Synermed, Inc. | 1997-09-25 |
| SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY (K972761) | Sealite Sciences, Inc. | 1997-09-25 |
| QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 AND 2, CONFORMANCEMCCLIQUICHEM UNASSAYED LIQUID CHEMISTRY CONTROL LEVELS (K973469) | Consolidated Technologies, Inc. | 1997-09-25 |
| CHOLESTEROL RAPID LIQUID REAGENT (K972853) | Reagents Applications, Inc. | 1997-09-24 |
| DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (K972580) | Bayer Corp. | 1997-09-22 |
| SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENT (K972743) | Sigma Diagnostics, Inc. | 1997-09-22 |
| GLUCOSITE TEST SYSTEM (K971145) | Gds Technology, LLC | 1997-09-17 |
| WAKO NEFA LINEARITY SET (K973072) | Wako Chemicals USA, Inc. | 1997-09-12 |
| TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY (K972666) | Hybritech, Inc. | 1997-09-11 |
| CLINITEK MICROALBUMIN REAGENT STRIPS (K972706) | Bayer Corp. | 1997-09-09 |
| AVL OMNI ANALYZER (K972733) | Avl Scientific Corp. | 1997-09-09 |
| VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300) (K973030) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-09-04 |
| FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300) (K972720) | Monobind | 1997-09-02 |
| ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT (K971458) | Diagnostic Specialties | 1997-09-02 |
| PREGNACOL PREGNANCY TEST (K972606) | Immunostics Inc., | 1997-08-29 |
| QUICKVUE ONE-STEP HCG-URINE (K972742) | Quidel Corp. | 1997-08-29 |
| CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL (K972976) | More Diagnostics | 1997-08-29 |
| CARDS Q.S. HCG-URINE; AND CONCISE PERFORMANCE PLUS HCG-URINE (K972748) | Quidel Corp. | 1997-08-29 |
| AIA-PACK TSH 3RD-GEN ASSAY (K972586) | Tosoh Medics, Inc. | 1997-08-29 |
| AG CHEMISTRY ANALYZER SYSTEM (K972409) | Landmark Scientific, Inc. | 1997-08-28 |
| TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL (K972868) | Bionostics, Inc. | 1997-08-28 |
| THE YELLOW IRIS URINALYSIS WORKSTATION (K972141) | Intl. Remote Imaging Systems | 1997-08-25 |
| AVL 9181 ELECTROLYTE ANALYZER (K972673) | Avl Scientific Corp. | 1997-08-20 |
| IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3) (K972861) | Instrumentation Laboratory CO | 1997-08-19 |
| DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY (K972782) | Dade Intl., Inc. | 1997-08-15 |
| QUANTIFY(901) (K972710) | Hematronix, Inc. | 1997-08-15 |
| IL TEST IRON (K972363) | Instrumentation Laboratory CO | 1997-08-15 |
| ABBOTT STREP A CONTROLS (K972182) | Abbott Diagnostics | 1997-08-13 |
| ACCURUN 117 HBEAG POSITIVE CONTROL (K972048) | Boston Biomedica, Inc. | 1997-08-12 |
| CHLAMYDIATROL AG (K972129) | Blackhawk Biosystems, Inc. | 1997-08-12 |
| ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS (K972250) | Roche Diagnostic Systems, Inc. | 1997-08-12 |
| ACCURUN 121 HAV IGM POSITIVE CONTROL (K971657) | Boston Biomedica, Inc. | 1997-08-12 |
| PRECICONTROL TUMOR MARKER 1 AND 2 (K972235) | Boehringer Mannheim Corp. | 1997-08-12 |
| DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA (K972337) | Diagnostic Chemicals , Ltd. | 1997-08-08 |
| PRECISION QID BLOOD GLUCOSE TEST STRIP, PRECISION G BLOOD GLUCOSE TEST STRIP (K971812) | Medisense, Inc. | 1997-08-08 |
| ACCURUN 120 HAV IGG POSITIVE CONTROL (K971406) | Boston Biomedica, Inc. | 1997-08-07 |
| ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL (K972307) | Boston Biomedica, Inc. | 1997-08-07 |
| SYNERMED TOTAL BILIRUBIN REAGENT KIT (K972716) | Synermed, Inc. | 1997-08-07 |
| ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P (K972721) | Roche Diagnostic Systems, Inc. | 1997-08-06 |
| PLASMA CATECHOLAMINE KIT (K972167) | Bioanalytical Systems, Inc. | 1997-08-04 |
| RANDOX ASSAYED SPECIFIC PROTEIN CONTROL (K972608) | Randox Laboratories, Ltd. | 1997-08-04 |
| UREA (K971309) | Derma Media Lab., Inc. | 1997-08-01 |
| GLUCOSE REAGENT (K970664) | Derma Media Lab., Inc. | 1997-08-01 |
| QUICKSTICK ONE STEP HCG PREGNANCY TEST (K972682) | Phamatech | 1997-08-01 |
| CODA AUTOMATED EIA ANALYZER (K972024) | Bio-Rad | 1997-07-30 |
| CARDIAC STATUS CONTROLS/TROPONIN I (K972687) | Spectral Diagnostics, Inc. | 1997-07-28 |
| IMMULITE FREE T4 (2-STEP) (K971792) | Diagnostic Products Corp. | 1997-07-25 |
| CARDIAC STATUS CONTROLS (K972408) | Spectral Diagnostics, Inc. | 1997-07-25 |
| PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST (K971825) | Randox Laboratories, Ltd. | 1997-07-24 |
| CHOLESTECH BUN/CREATININE TEST SYSTEM (K972012) | Cholestech Corp. | 1997-07-24 |
| COLORMATE III (K964590) | Chromatics Color Sciences Intl., Inc. | 1997-07-24 |
| AMMONIA/IRON STANDARD KIT (K972333) | Verichem Laboratories, Inc. | 1997-07-23 |
| TARGET CARDIAC TROPONIN I TEST (K972094) | Texas Immunology, Inc. | 1997-07-23 |
| PERSONALLAB AUTOMATED MICROPLATE ANALYZER (K971761) | Biochem Immunosystems (U.S.), Inc. | 1997-07-22 |
| EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5) (K972041) | Sigma Diagnostics, Inc. | 1997-07-22 |
| LIQUID GLUCOSE (HEXOKINASE) REAGENT SET (K971754) | Pointe Scientific, Inc., | 1997-07-22 |