| IMX SELECT ANALYZER (K912368) | Abbott Laboratories | 1991-09-11 |
| OPUS(R) PLUS ANALYZER (K913295) | Pb Diagnostic Systems, Inc. | 1991-09-11 |
| CHOLINESTERASE LINEARITY CONTROL (K913496) | Creative Laboratory Products, Inc. | 1991-09-11 |
| ABBOTT QUICKSTART BICARBONATE TEST CO2 ITEM# 5A22 (K912806) | Em Diagnostic Systems, Inc. | 1991-09-11 |
| NOVA 13 ANALYZER (K912561) | Nova Biomedical Corp. | 1991-09-11 |
| AMYLASE REAGENT (PROCEDURE 577) (K913858) | Sigma Diagnostics, Inc. | 1991-09-11 |
| FIRST CHOICE(TM) (K912732) | Polymer Technology Corp. | 1991-09-10 |
| AIA-PACK FT4 (K913493) | Tosoh Corp. | 1991-09-10 |
| ENZYME LINEARITY CONTROL (K912718) | Phoenix Diagnostics, Inc. | 1991-09-06 |
| KODAK EKTACHEM DTII SYSTEM (K912844) | Eastman Kodak Company | 1991-09-04 |
| ROSYS MODELS 100 AND 200 (K913664) | Packard Instrument Co., Inc. | 1991-08-30 |
| METROLAB MODEL 1500 (K910806) | Laboratorio Rodriguez Corswant S.R.L. | 1991-08-30 |
| TANDEM-E TSH CALIBRATION VERIFICATION CONTROL SET (K912439) | Hybritech, Inc. | 1991-08-28 |
| PROACT CHOLESTEROL SYSTEMS (K912212) | Boehringer Mannheim Corp. | 1991-08-28 |
| KODAK EKTACHEM DT SLIDES (ALB) (K913195) | Eastman Kodak Company | 1991-08-26 |
| KODAK EKTACHEM DT SLIDES (LAC) (K913197) | Eastman Kodak Company | 1991-08-26 |
| BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY (K913091) | American Laboratory Products Co., Ltd. | 1991-08-26 |
| NEW-VENT (K911809) | Concord/Portex | 1991-08-26 |
| URINE COLLECTION KIT/DEVICE (K913330) | Medical Implements, Inc. | 1991-08-26 |
| STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY (K913236) | Baxter Healthcare Corp | 1991-08-16 |
| SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE) (K911217) | Serono-Baker Diagnostics, Inc. | 1991-08-16 |
| ENZYMATICS, INC., TOTAL CHOLESTEROL TEST (K911692) | Enzymatics C/O Burditt,Bowles,Radzius & Ruberry | 1991-08-16 |
| HIGH DENSITY LIPOPROTEIN CHOLESTEROL (K912823) | Creative Laboratory Products, Inc. | 1991-08-16 |
| OPUS(R) PROLACTIN TEST SYSTEM (K913280) | Pb Diagnostic Systems, Inc. | 1991-08-16 |
| DIRECTIGEN 1-2-3(TM) HCG TEST (K913122) | Quidel Corp. | 1991-08-16 |
| DADE IAC-X COMPREHENSIVE IMMUNOASSAY CONTROL (K912455) | Baxter Healthcare Corp | 1991-08-12 |
| MILENIA TOTAL T4, CATALOG: MKT41,5 (K912541) | Diagnostic Products Corp. | 1991-08-12 |
| MAGIC LITE TSH (HS) IMMUNOASSAY (K912583) | Ciba Corning Diagnostics Corp. | 1991-08-12 |
| REFLOTRON CREATININE TEST TABS (K913105) | Boehringer Mannheim Corp. | 1991-08-12 |
| FSH IRMA IMMUNOMAG (K912804) | Pantex, Div. Bio-Analysis, Inc. | 1991-08-12 |
| BIOTROL UIBC REAGENT (K912795) | Biotrol, USA, Inc. | 1991-08-12 |
| ROCHE REAGENT FOR AMMONIA (K913124) | Roche Diagnostic Systems, Inc. | 1991-08-12 |
| SHBG (K912850) | Wien Laboratories, Inc. | 1991-08-12 |
| ABBOTT QUICKSTART PHOSPHORUS(PHOS) ITEM #5A14 (K912809) | Em Diagnostic Systems, Inc. | 1991-08-12 |
| LUMATAG T4 CHEMILUMINESCENCE ASSAY (K911985) | London Diagnostics, Inc. | 1991-08-02 |
| SYNERMED SERUM IRON-600 REAGENT KIT (K912912) | Synermed, Inc. | 1991-07-30 |
| ABBOTT QUICK START GLUCOSE (GLUE) ITEM# 5A15 (K912808) | Em Diagnostic Systems, Inc. | 1991-07-30 |
| ABBOTT QUICKSTART TOTAL PROTEIN TEST ITEM# 5A13 (K912810) | Em Diagnostic Systems, Inc. | 1991-07-30 |
| CHOLESTECH LIPID MONITORING SYS. (K912136) | Cholestech Corp. | 1991-07-30 |
| TOTAL IRON & UNSAT IRON BIND CAP/IRON BIND CONTROL (K912725) | Creative Laboratory Products, Inc. | 1991-07-30 |
| REP ALP-15, 8, & 4 KITS (K912603) | Helena Laboratories | 1991-07-30 |
| LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY (K912858) | London Diagnostics, Inc. | 1991-07-30 |
| MILENIA ESTRADIOL (K912917) | Diagnostic Products Corp. | 1991-07-30 |
| MICROTRAK MANAGER (K912959) | Syva Co. | 1991-07-26 |
| ABBOTT QUICKSTART GAMMA-GLUTAMYTRANSFERASE TEST (K913024) | Em Diagnostic Systems, Inc. | 1991-07-26 |
| ROBOTIC SAMPLE PROCESSOR (K912036) | Tecan U.S., Ltd. | 1991-07-26 |
| MAGNESIUM ASSAY KIT, CAT.# 100-12 (K912825) | Diagnostic Chemicals, Ltd. (Usa) | 1991-07-26 |
| ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE) (K912318) | Serono-Baker Diagnostics, Inc. | 1991-07-25 |
| QUIKPAC-II ONE STEP PREGNANCY HOME TEST (K912316) | Syntron Bioresearch, Inc. | 1991-07-24 |
| AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT (K912733) | Amersham Corp. | 1991-07-22 |
| MICRO ALBUMIN EIA TEST KIT (K912543) | Immuno Diagnostic Center, Inc. | 1991-07-19 |
| IMMUNOCARD HCG ONE STEP (I-S) TEST KIT (K911826) | Disease Detection International, Inc. | 1991-07-19 |
| AUTOMATED BIOCHEMICAL ANALYZER (WAK0-20R & 30R) (K912024) | Wako Chemicals USA, Inc. | 1991-07-19 |
| TARGET MICROALBUMINURIA TEST (K912246) | Texas Immunology, Inc. | 1991-07-19 |
| ROCHE REAGENT FOR C02 (K911838) | Roche Diagnostic Systems, Inc. | 1991-07-19 |
| ELECTROLYTE CONTROL (K912513) | Verichem Laboratories, Inc. | 1991-07-19 |
| CALCITONIN KIT MITSUBISHI YUKA (K912536) | Mitsubishi Yuka America, Inc. | 1991-07-18 |
| MAGNETIC HDL CHOLESTEROL TEST (K911906) | Reference Diagnostics, Inc. | 1991-07-18 |
| KING DIAGNOSTICS GLUCOSE (HK) REAGENT STRIP TEST (K912251) | King Diagnostics, Inc. | 1991-07-18 |
| NOVA 12 ANALYZER (K912560) | Nova Biomedical Corp. | 1991-07-17 |
| LINEARITY TEST KITS (K912441) | Boehringer Mannheim Corp. | 1991-07-17 |
| ULTRA BLOOD GLUCOSE MONITORING SYSTEM (K912440) | Home Diagnostics, Inc. | 1991-07-17 |
| REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165 (K912386) | Helena Laboratories | 1991-07-17 |
| SYNERMED PHOSPHORUS REAGENT KIT (K912569) | Synermed, Inc. | 1991-07-17 |
| TRACE TOTAL/DIRECT BILIRUBIN REAGENT (K911866) | Trace Scientific , Ltd. | 1991-07-17 |
| AMERLITE CK-MB ASSAY (K912766) | Amersham Corp. | 1991-07-17 |
| ISE/CI- (K912647) | Boehringer Mannheim Corp. | 1991-07-17 |
| ISE/NA+ (K912648) | Boehringer Mannheim Corp. | 1991-07-17 |
| VISION BG TEST STRIP (K911624) | British-American Medical, Inc. | 1991-07-17 |
| ISE/K+ (K912649) | Boehringer Mannheim Corp. | 1991-07-15 |
| PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT (K912231) | Intl. Immunoassay Laboratories, Inc. | 1991-07-08 |
| NOVA 1 SODIUM/POTASSIUM/HEMATOCRIT ANALYZER (K912559) | Nova Biomedical Corp. | 1991-07-01 |
| AMYLASE REAGENT (K912519) | Genzyme Corp. | 1991-07-01 |
| CHEM-LINK DATA BASE MANAGER (K912413) | Technicon Instruments Corp. | 1991-07-01 |
| I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK (K912387) | I-Stat Corp. | 1991-07-01 |
| KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON (K911801) | Gds Technology, LLC | 1991-07-01 |
| IMX TOTAL B-HCG (K912535) | Abbott Laboratories | 1991-07-01 |
| KETO-340 II (K912373) | Ihara Medics U.S., Inc. | 1991-07-01 |
| IMX HCG (K912534) | Abbott Laboratories | 1991-07-01 |
| DELFIA(R) 17 -OH-PROGESTERON KIT (K912026) | Pharmacia Diagnostics, Inc. | 1991-06-25 |
| MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST (K911634) | Immunotech Corp. | 1991-06-24 |
| OBA(TM) SERUM HCG ASSAY (K911047) | Adeza Biomedical | 1991-06-24 |
| OBA(TM) READER (K911045) | Adeza Biomedical | 1991-06-24 |
| SYRINGE TIP CAP (K911638) | Concord/Portex | 1991-06-21 |
| STRATUS(R) HTSH FLUORMETRIC ENZYME IMMUNOASSAY (K912241) | Baxter Healthcare Corp | 1991-06-20 |
| NEONATAL TSH (125I) IMMUNORADIOMETRIC ASSAY (K912324) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-06-20 |
| IMMULITE(TM) HCG (K911796) | Cirrus Diagnostics, Inc. | 1991-06-20 |
| NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT (K911839) | Pantex, Div. Bio-Analysis, Inc. | 1991-06-18 |
| MODULE: NOVA NUCLEUS TMG MODULE FLUID PACK (K912321) | Nova Biomedical Corp. | 1991-06-17 |
| ANEMIA I, II (K911984) | Ciba Corning Diagnostics Corp. | 1991-06-13 |
| IL PHOENIX(TM), MODEL 905 CHEM/ELECT ANALYZER (K912016) | Instrumentation Laboratory CO | 1991-06-10 |
| SYVA EDMS (K912055) | Syva Co. | 1991-06-10 |
| DADE LIID-TROL TL TRI-LEVEL LIPID CONTROL (K911854) | Baxter Healthcare Corp | 1991-06-10 |
| MARK 5 ROBOTIC PIPETTOR (K912228) | Diagnostic Products Corp. | 1991-06-06 |
| SYNERMED UREA NITROGEN REAGENT KIT (K911248) | Synermed, Inc. | 1991-06-03 |
| DIRECTIGEN 1-2-3 PREGNANCY CONTROLS (K911664) | Quidel Corp. | 1991-05-31 |
| SR1 ESTRADIOL ENZYME IMMUNOASSAY (K911396) | Serono-Baker Diagnostics, Inc. | 1991-05-28 |
| SRI TSH IMMUNENZYMETRIC ASSAY (K910837) | Serono-Baker Diagnostics, Inc. | 1991-05-24 |
| TURBO ACCELERATOR W/CLIN DIAG SOFTWARE CARTRIDGE (K911438) | Bio-Tek Instruments, Inc. | 1991-05-23 |
| MILENIA PROGESTERONE (K911512) | Diagnostic Products Corp. | 1991-05-22 |