meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
56
Latest Decision
1993-05-26

Clearances · page 58 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K930306 COBAS CORE LH EIA Roche Diagnostic Systems, Inc. CEP Class I 1993-05-26
K926394 VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY Syva Co. CEP Class I 1993-05-26
K931141 BIOTROL AMYLASE CNPG3 Biotrol, USA, Inc. CIJ Class II 1993-05-26
K931493 KODAK EKTACHEM TOTAL IRON-BINDING CAPACITY KIT Eastman Kodak Company JMO Class I 1993-05-26
K926322 ACCESS(R) CORTISOL REAGENTS Bio-Rad Laboratories, Inc. JFT Class II 1993-05-26
K926443 COBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORS Roche Diagnostic Systems, Inc. KHQ Class II 1993-05-20
K931110 RADIAS FREE T4 ENZYME IMMUNOASSAY Bio-Rad CEC Class II 1993-05-20
K924859 AIA-PACK IGE CALIBRATION VERIFICATION TEST SET Tosoh Medics, Inc. JJX Class I 1993-05-14
K926393 VIDAS THYROXINE (T4) ASSAY (T4) Biomerieux Vitek, Inc. KLI Class II 1993-05-13
K931139 DOCULMENT(R) CHEM VI CALIBRATION VERIF TEST SET Casco Standards JJY Class I 1993-05-12
K930489 AMYLASE METHOD/DIMENSION(R) CLINICAL CHEMISTRY SYS E.I. Dupont DE Nemours & Co., Inc. JJE Class I 1993-05-12
K931467 CHEK-STIX CONTROL STRIPS FOR URINALYSIS Heraeus Kulzer, Inc. JJW Class I 1993-05-11
K930932 SYNERMED CREATINE KINASE REAGENT KIT Synermed, Inc. CGS Class II 1993-05-11
K930484 DELFIA(R) HGH KIT Wallac OY CFL Class I 1993-05-11
K931361 IL TEST PHOSPHORUS Instrumentation Laboratory CO CEO Class I 1993-05-11
K931367 VACUTAINER BRAND LUER ADAPTER Bd Becton Dickinson Vacutainer Systems Preanalytic JKA Class II 1993-05-11
K924673 CLEARVIEW HCG Unipath , Ltd. JHI Class II 1993-05-11
K931409 IMMULITE CORTISOL Diagnostic Products Corp. CGR Class II 1993-05-11
K930074 IN-VITRO DIAGNOSTIC REAGENT SET Horizon Diagnostics, Inc. JGJ Class I 1993-05-11
K931227 USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000 U.S. Drug Testing, Inc. KZR Class I 1993-05-06
K930874 LD-1 CONTROL-LEVEL 1 & 2 Cala Diagnostics JJX Class I 1993-04-22
K925935 OLYMPUS REPLY CLINICAL CHEMISTRY ANALYZER Olympus Corp. JJQ Class I 1993-04-22
K930898 RADIAS AUTOMATED IMMUNOASSAY SYSTEM Bio-Rad JJI Class I 1993-04-21
K930166 IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R Em Diagnostic Systems, Inc. JIY Class I 1993-04-21
K925612 HI CHEM ELECTROLYTE BUFFER Hichem Diagnostics JGS Class II 1993-04-20
K925550 HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806 Hichem Diagnostics CDS Class II 1993-04-20
K925842 BECTON DICKINSON SIMULTRAC COMPONENT SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic CEC Class II 1993-04-20
K925551 HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807 Hichem Diagnostics CGA Class II 1993-04-20
K931050 CARDIO REP CK ISOENZYME KIT - 3310 Helena Laboratories JHW Class II 1993-04-20
K930875 CKMB CONTROL - LEVEL 1,2,3 Cala Diagnostics JJT Class I 1993-04-13
K930873 CKMB ISOENZYME CONTROL-LEVEL 1,2.3 Cala Diagnostics JJT Class I 1993-04-13
K930359 CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305 Helena Laboratories JHT Class II 1993-04-12
K925703 OPUS SEROLOGY CONTROLS Pb Diagnostics, Inc. MJX Class I 1993-04-08
K930070 HEMOCARD HEMOGLOBIN E Isolab, Inc. CKA Class I 1993-04-08
K930488 BESURE PLUS/(MIDSTREAM) ONE STEP PREG HOME TEST Syntron Bioresearch, Inc. LCX Class II 1993-04-06
K926386 VISTA PROLACTIN ASSAY Syva Co. CFT Class I 1993-03-29
K930609 SAS(TM) MONOCLONAL HCG-SLIDE Sa Scientific, Inc. JHJ Class II 1993-03-29
K925794 TRACE MICROPROTEIN REAGENT Trace America, Inc. JGQ Class II 1993-03-29
K930660 CREATINE KINASE (CK) REAGENT SET Pointe Scientific, Inc., CGS Class II 1993-03-29
K925326 ELECTROPHORESIS CONTROL LEVEL 1 Seradyn, Inc. JJY Class I 1993-03-26
K930014 PROCLINIC ONE-STEP DIPSTICK PREGNANCY TEST Vanguard Biomedical Corp. JHI Class II 1993-03-25
K925783 AUTOSTAT ANTI-DSDNA Cogent Diagnotics , Ltd. JJX Class I 1993-03-22
K925277 CIBA CORNING ACS HCG IMMUNOASSAY Ciba Corning Diagnostics Corp. JHI Class II 1993-03-19
K926356 PRECISE(TM) HCG(URINE/SERUM) AND PRCISE(TM) PREG Becton Dickinson Advanced Diagnostics JHI Class II 1993-03-18
K930640 PRECISE PREGNANCY Bd Becton Dickinson Vacutainer Systems Preanalytic LCX Class II 1993-03-18
K926563 AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT Bio-Chem Laboratory Systems, Inc. CDX Class II 1993-03-18
K925877 DC-UIBC-CAL Diagnostic Chemicals, Ltd. (Usa) JIS Class II 1993-03-18
K923532 NATIONAL SCREENING INSTITUTE MICRO-PLATE TSH ASSAY Solarcare Technologies Corp,Inc. JLW Class II 1993-03-12
K924802 CALIBRATION VERIFICATION KIT OR CVK Radiometer America, Inc. JJY Class I 1993-03-09
K925846 IMMULITE PROLACTIN Diagnostic Products Corp. CFT Class I 1993-03-05
K924860 AIA-PACK AFP CALIBRATION VERIFICATION TEST SET Tosoh Medics, Inc. JJX Class I 1993-03-04
K930185 OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP Princeton Biomedix CEP Class I 1993-03-04
K914432 ACCUMETER(R) CHOLESTEROL SELF-TEST Chemtrak, Inc. CHH Class I 1993-03-02
K924361 VACUPLUS TUBES WITH GREEN STOPPERS Starplex Scientific, Inc. JKA Class II 1993-03-01
K925649 NAT. SCREENING INSTITUTE MICRO-PLATE FREE T4 ASSAY Solarcare Technologies Corp,Inc. CEC Class II 1993-03-01
K925256 QUANTIMETRIX URINALYSIS MICROSCOPICS CONTROL Quantimetrix Corp. JJY Class I 1993-03-01
K925637 ACCESS HTSH ASSAY Bio-Rad Laboratories, Inc. JLW Class II 1993-03-01
K924364 VACUPLUS TUBES WITH GREY STOPPERS Starplex Scientific, Inc. JKA Class II 1993-03-01
K924362 VACUPLUS TUBES WITH LAVANDER STOPPERS Starplex Scientific, Inc. JKA Class II 1993-03-01
K926345 TRIODOTHYRONINE (TC) COATED TUBE RIA Monobind CDP Class II 1993-02-25
K924497 STAT PROFILE 9 ANALYZER Nova Biomedical Corp. CHL Class II 1993-02-23
K925611 HI CHEM ELECTROLYTE REFERENCE REAGENT Hichem Diagnostics JGS Class II 1993-02-23
K924061 CANCER ANTIGEN CONTROL Polymedco, Inc. JJY Class I 1993-02-23
K923316 EXPRESSO CARTRIDGE Bio-Rad Laboratories, Inc. JQP Class I 1993-02-23
K925101 SYSTEMATE PLUS CALIBRATOR Em Diagnostic Systems, Inc. JIX Class II 1993-02-23
K925906 NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL Analytical Control Systems, Inc. JJX Class I 1993-02-18
K926511 SYNERMED SINGLE REAGENT CREATININE KIT Synermed, Inc. CGX Class II 1993-02-18
K922754 TANDEM-E IGE II CALIBRATION VERIFICATION SET Hybritech, Inc. JJX Class I 1993-02-17
K926342 VISTA(R) HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY Syva Co. JHI Class II 1993-02-17
K923579 MINIVIDAS INSTRUMENT Biomerieux Vitek, Inc. JJE Class I 1993-02-12
K925498 VIDAS ESTRADIOL (E2) ASSAY Biomerieux Vitek, Inc. CHP Class I 1993-02-12
K925552 HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812 Hichem Diagnostics JFL Class II 1993-02-12
K925553 HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813 Hichem Diagnostics JFL Class II 1993-02-12
K926060 SYNCHRON CX5CE CLINICAL ANALYZER Beckman Instruments, Inc. JJE Class I 1993-02-12
K926198 ACCESS TOTAL BHCG ASSAY Bio-Rad Laboratories, Inc. JHI Class II 1993-02-08
K924363 VACUPLUS(R) STAR-SEP(TM) Starplex Scientific, Inc. JKA Class II 1993-02-08
K925603 OLYMPUS CHOLESTEROL REAGENT Olympus Corp. CHH Class I 1993-02-08
K924368 OLYMPUS ALBUMIN REAGENT Olympus Corp. CIX Class II 1993-02-08
K925339 OLYLMPUS ALANINE AMINOTRANSFERASE REAGENT Olympus Corp. CKA Class I 1993-02-05
K925880 KODAK AMERLITE CK-MB CONTROL SERA LAN.4413 Eastman Kodak Company JJX Class I 1993-02-05
K924703 LACTATE DEHYDROGENASE (LD) TEST ITEM #65418 Em Diagnostic Systems, Inc. CFJ Class II 1993-02-05
K925188 ABBOTT QUICKSTART LD-1, MODIFICATION Em Diagnostic Systems, Inc. JGF Class II 1993-02-05
K926320 REFLAB SYSTEM PACK LIQUID CO2 REAGENT Medical Analysis Systems, Inc. CHS Class II 1993-02-03
K922944 IMMUCHEM LH-MW ELISA Icn Biomedicals, Inc. CEP Class I 1993-02-02
K926204 SAS ONE STEP PREGNANCY Sa Scientific, Inc. JHI Class II 1993-02-02
K924508 CHOLESTEROL TEST ITEM# 42374/93, 42322/R1 Em Diagnostic Systems, Inc. CHH Class I 1993-01-28
K926359 CLINITEK 200+ URINE CHEMISTRY ANALYZER Heraeus Kulzer, Inc. KQO Class I 1993-01-28
K924547 NOVA 8 CRT ANALYZER Nova Biomedical Corp. JGS Class II 1993-01-28
K926518 ISE CALIBRATOR FOR DUPONT DIMENSION Alko Diagnostic Corp. JIX Class II 1993-01-28
K924021 POWER SUPPLY The Binding Site, Ltd. JJN Class I 1993-01-28
K925479 SUGAR CHEX LINEARITY FOR THE ONE TOUCH Streck Laboratories, Inc. JJX Class I 1993-01-28
K922811 ROCHE COBAS FUTURA GLUCOSE Roche Diagnostic Systems, Inc. CFR Class II 1993-01-27
K926144 URINE MAGNESIUM METHOD FOR TECHNICON CHEM SYSTEMS Heraeus Kulzer, Inc. JGJ Class I 1993-01-27
K925913 ACCESS(R) FREE T4 ASSAY Bio-Rad Laboratories, Inc. CEC Class II 1993-01-27
K925547 MAXSOFTWARE Diagnostic Products Corp. JQW Class I 1993-01-26
K924710 TRIGLYCERIDES Em Diagnostic Systems, Inc. CDT Class I 1993-01-26
K926308 LIFESIGN HCG - ONE STEP HOME PREGNANCY TEST Princeton Biomedix LCX Class II 1993-01-26
K925155 OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT Olympus Corp. CIT Class II 1993-01-26
K925113 OLYMPUS URIC ACID REAGENT Olympus Corp. KNK Class I 1993-01-26
K926095 REFRACTROL-SP Medical Specialties, Inc. JJX Class I 1993-01-26

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