meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
55
Latest Decision
1992-08-10

Clearances · page 61 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K922697 DU PONT ACA PLUS IMMUNOASSAY SYSTEM HCG METHOD E.I. Dupont DE Nemours & Co., Inc. JHI Class II 1992-08-10
K923165 AMERLITE FREE THYROID CONTROL SERA LAN.4002 Eastman Kodak Company JJY Class I 1992-08-10
K922823 ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTS Bio-Rad Laboratories, Inc. CGN Class II 1992-08-05
K922835 CALCIUM (AZ III) REAGENT King Diagnostics, Inc. CJY Class II 1992-08-04
K921855 BIOTROL BICARBONATE STANDARDS Biotrol, USA, Inc. JIS Class II 1992-08-03
K922792 ZITHROMAX Difco Laboratories, Inc. JNT Class I 1992-07-30
K921745 HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO Hybritech, Inc. JFH Class II 1992-07-30
K922904 RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II Reagents Applications, Inc. JJX Class I 1992-07-30
K922032 ENZIP URINARY MICROALBUMIN TEST Diagnostic Specialties JIR Class I 1992-07-30
K923268 AFFIRM PROCESSOR Microprobe Corp. JQW Class I 1992-07-30
K922884 OLYMPUS ALANINE AMINOTRANSFERASE REAGENT Olympus Corp. CKA Class I 1992-07-28
K921302 VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM Vitek Systems, Inc. JHI Class II 1992-07-28
K921180 COBAS CORE IMMUNOCHEMISTRY SYSTEM Roche Diagnostic Systems, Inc. JJQ Class I 1992-07-28
K922885 OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT Olympus Corp. CIT Class II 1992-07-28
K921937 NOVA NUCLEUS CLINICAL CHEMICAL SYST, MODIFICATION Nova Biomedical Corp. JGS Class II 1992-07-27
K922024 REP SPE PLUS (ACID BLUE) SYSTEM,# 3173/3174/3175 Helena Laboratories CEF Class I 1992-07-23
K920653 IL TEST BILIRUBIN TOTAL/DIRECT Instrumentation Laboratory CO CIG Class II 1992-07-23
K921718 OLYMPUS ISE MODULE Olympus Corp. JGS Class II 1992-07-21
K921844 KODAK EKTACHEM DT SLIDES (NBIL) Eastman Kodak Company CIG Class II 1992-07-21
K922138 VISTA ULTRASENSITIVE HTSH ASSAY Syva Co. JLW Class II 1992-07-21
K922139 VISTA IMMUNOASSAY SYSTEM -- MODIFICATION Syva Co. JJE Class I 1992-07-21
K921249 WAKO AUTOKIT LIPASE-COLOR Wako Chemicals USA, Inc. CHI Class I 1992-07-21
K923021 AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM Tosoh Corp. KHO Class I 1992-07-21
K922784 SYNERMED UIBC REAGENT KIT Synermed, Inc. JMO Class I 1992-07-21
K922215 NOVA 14 NA/K/CL/GLU/BUN ANALYZER Nova Biomedical Corp. JGS Class II 1992-07-17
K922369 OLYMPUS ALBUMIN REAGENT Olympus Corp. CIX Class II 1992-07-17
K920556 TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET Hybritech, Inc. JJX Class I 1992-07-17
K921252 TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL Hybritech, Inc. JJX Class I 1992-07-17
K922756 OLYMPUS URIC ACID REAGENT Olympus Corp. KNK Class I 1992-07-17
K915345 STAT K SYSTEM Portable Diagnostic Services, Inc. CEM Class II 1992-07-16
K922232 OLYMPUS GLUCOSE REAGENT Olympus Corp. CFR Class II 1992-07-16
K922361 OLYMPUS TOTAL PROTEIN REAGENT Olympus Corp. CEK Class II 1992-07-16
K922108 KING DIAGNOSTICS AST (GOT) REAGENT King Diagnostics, Inc. CIT Class II 1992-07-15
K920531 WAKO AUTOKIT MICRO TP Wako Chemicals USA, Inc. CEK Class II 1992-07-14
K920285 BLOOD GAS/ISE LINEARITY CONTROL Phoenix Diagnostics, Inc. JJS Class I 1992-07-14
K922459 OLYMPUS CREATINE KINASE REAGENT Olympus Corp. CGS Class II 1992-07-13
K922233 OLYMPUS CALCIUM REAGENT Olympus Corp. CIC Class II 1992-07-10
K922046 LYPHOCHEK UNASSAYED CHEMISTRY CONTROL LEVEL 3 Bio-Rad JJY Class I 1992-07-10
K921205 DSL ACTIVE ALDOSTERONE (DSL 8600) Diagnostic Systems Laboratories, Inc. CJM Class II 1992-07-10
K922597 OLYMPUS UREA NITROGEN (BUN) REAGENT Olympus Corp. CDQ Class II 1992-07-10
K922072 KODAK EKTACHEM 250 ANALYER Eastman Kodak Company JJE Class I 1992-07-10
K921520 VACUTAINER BRAND LUER ADAPTER Bd Becton Dickinson Vacutainer Systems Preanalytic JKA Class II 1992-07-10
K922676 CORTISOL CHEMILUMINESCENCE ASSAY Nichols Institute CGR Class II 1992-07-10
K922736 KODAK AMERLITE TSH-30 ULTRASENSITIVE STANDARD SERA Eastman Kodak Company JLW Class II 1992-07-10
K922468 ANGEL WING SETS -- MODIFIED Mbo Laboratories, Inc. GIM Class II 1992-07-10
K922284 ELEGANCE FT4 ELISA Bioclone Australia Pty , Ltd. CEC Class II 1992-07-10
K922290 SINGLE-STEP PREGNANCY, HCG TEST American Medical Products, Inc. JHI Class II 1992-07-09
K922762 ROCHE REAGENT FOR URIC ACID--MODIFICATION Roche Diagnostic Systems, Inc. KNK Class I 1992-07-09
K920636 DADE URINE CHEMISTRY CONTROL LEVELS I AND II Baxter Diagnostics, Inc. JJY Class I 1992-07-07
K921935 THYROXINE (T4) COATED TUBE RIA Monobind CDX Class II 1992-07-07
K921958 ELISA TUBE TSH TEST Bio Clinic Co. JLW Class II 1992-07-02
K922229 OLYMPUS TRIGLYCERIDE REAGENT Olympus Corp. CDT Class I 1992-07-02
K921661 BOEHRINGER MANNHEIM/ HITACHI 911 ANALYZER Boehringer Mannheim Corp. JJE Class I 1992-06-30
K922357 RNA MEDICAL'S EQUIL 55 Bionostics, Inc. JJS Class I 1992-06-30
K921700 TSH ENZYME IMMUNOASSAY TEST KIT CAT. NO. KIF4093 Medix Biotech, Inc. JLW Class II 1992-06-29
K922386 RNA MEDICAL TONOMETER Bionostics, Inc. LCH Class I 1992-06-26
K922230 OLYMPUS GGT REAGENT Olympus Corp. JQB Class I 1992-06-25
K922220 OLYMPUS AU5200 CLINICAL CHEMISTRY ANALYZER Olympus Corp. JJE Class I 1992-06-25
K921614 MILENIA FOLIC ACID Diagnostic Products Corp. CGN Class II 1992-06-25
K922612 CHOLESTECH LIPID MONITORING SYSTEM, TOTAL CHOLESTE Cholestech Corp. CHH Class I 1992-06-24
K921904 THYROXINE (FPIA) KIT Tudor Laboratories, Inc. KLI Class II 1992-06-24
K921795 BACTON(TM), AUTO-APO A-1 REAGENT Bacton Assay Systems, Inc. MSJ Class I 1992-06-23
K921862 BACTON(TM), AUTO-APO B REAGENT Bacton Assay Systems, Inc. MSJ Class I 1992-06-22
K920927 KEMTROL SERUM CONTROL-NORMAL CAT NO. 7024 Helena Laboratories JJY Class I 1992-06-19
K920974 BACTIDROP ACRIDINE ORANGE Remel Co. JFO Class II 1992-06-19
K921816 VITEK IMMUN ASSAY SYS(VIDAS) THYROI STIM HOR ASSAY Biomerieux Vitek, Inc. JLW Class II 1992-06-18
K922043 ROCHE CALIBRATOR SERUM Roche Diagnostic Systems, Inc. JIX Class II 1992-06-16
K921689 CEDIA RED BLOOD CELL FOLATE REAGENT PACK Microgenics Corp. CGN Class II 1992-06-16
K921746 VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM Biomerieux Vitek, Inc. CGJ Class I 1992-06-16
K920942 OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZER Olympus Corp. JJG Class I 1992-06-10
K921568 ORS-100 Mnlase, Inc. JRM Class I 1992-06-09
K921704 IMMULITE(R) FSH Cirrus Diagnostics, Inc. CGJ Class I 1992-06-09
K921569 ORS-200 Mnlase, Inc. JRM Class I 1992-06-09
K921286 LIQUICHEK LIPIDS CONTROL LEVELS 1 AND 2 Bio-Rad JJY Class I 1992-06-09
K921763 TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY Hybritech, Inc. JHY Class II 1992-06-09
K921678 CIBA CORNING ACS FOLATE IMMUNOASSAY Ciba Corning Diagnostics Corp. JIX Class II 1992-06-09
K921570 ORS-300 Mnlase, Inc. JRM Class I 1992-06-09
K922109 KING DIAGNOSTICS ALT (GPT) REAGENT King Diagnostics, Inc. CKA Class I 1992-06-04
K921099 SYNTRON QUIKSTRIP/E.Z. STRIP PREGNANCY HOME TEST Syntron Bioresearch, Inc. LCX Class II 1992-05-29
K921778 DIRECTDRAW SUPERSERUM International Technidyne Corp. GIM Class II 1992-05-28
K921903 THYROXINE CALIBRATOR KIT Tudor Laboratories, Inc. JIS Class II 1992-05-26
K921534 DSL DHEA (DSL 8900) Diagnostic Systems Laboratories, Inc. JKL Class I 1992-05-26
K921677 BIOTROL MAGNESIUM (MAGON) Biotrol, USA, Inc. JGJ Class I 1992-05-26
K921037 APOLIPOPROTEIN TEST SYSTEM Baxter Diagnostics, Inc. MSJ Class I 1992-05-22
K921629 N-TACT(R) PTH SP KIT Incstar Corp. CEW Class II 1992-05-14
K921625 CALCIUM-ARSENAZO III REAGENT SET Pointe Scientific, Inc., CIC Class II 1992-05-13
K921211 NOW PREGNANCY TEST KIT Bio Clinic Co. JHI Class II 1992-05-07
K921016 SYNERMED ALT/GPT REAGENT KIT Synermed, Inc. CKA Class I 1992-05-07
K920926 KEMTROL SERUM CONTROL-ABNORMAL Helena Laboratories JJY Class I 1992-05-07
K921212 MIRCO ELISA HPL TEST KIT Bio Clinic Co. JHI Class II 1992-05-07
K920109 IMX INSULIN Abbott Laboratories CFP Class I 1992-05-07
K915896 MICROLITE MICROTITER PLATE LUMINOMETER ML2250/MODI Dynatech Laboratories, Inc. JJQ Class I 1992-05-04
K920402 ROCHE COBAS MIRA PLUS Roche Diagnostic Systems, Inc. JJE Class I 1992-04-29
K921636 VACUTAINER(R) BRAND SAFETY-LOK BLOOD COLLECT SET Bd Becton Dickinson Vacutainer Systems Preanalytic GIM Class II 1992-04-29
K921089 LYPHOCHEK(R) FRUCTOSAMINE CONTROL Bio-Rad JJX Class I 1992-04-29
K921455 ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD E.I. Dupont DE Nemours & Co., Inc. CFE Class II 1992-04-29
K921206 HCG CONTROL Polymedco, Inc. JJX Class I 1992-04-29
K921005 AUTOLOADER Innovative Medical Systems, Inc. JQW Class I 1992-04-29
K921806 VACUTAINER(R) BRAND SST(R) AND CAT TUBES Bd Becton Dickinson Vacutainer Systems Preanalytic JKA Class II 1992-04-29
K915675 ELECTRODE, ION SPECIFIC Alko Diagnostic Corp. JFP Class II 1992-04-29

13,065 clearances in the Clinical Chemistry panel. Data: openFDA.