meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
61
Latest Decision
1988-06-01

Clearances · page 78 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K881474 VISION(R) LDH (LACTATE DEHYDROGENASE) Abbott Laboratories CFJ Class II 1988-06-01
K881809 REP LIPO KIT CAT. NO 3180 Helena Laboratories JHO Class I 1988-06-01
K881498 SYNCHRON CX(TM)4 CLINICAL ANALYZER Beckman Instruments, Inc. JJE Class I 1988-06-01
K881351 IMACK-MB, CATALOGS 602-1, 602-1/125, 602-1/225 Intl. Immunoassay Laboratories, Inc. JHY Class II 1988-06-01
K880584 URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C Mach Diag. C/O Wichita State University CDM Class I 1988-05-31
K880418 INCOS 50 MASS SPECTROMETER Finnigan Corp. DOP Class I 1988-05-31
K881239 GAMMA GLUTAMYL TRANSFERASE REAGENT SET Tech-Neal Scientific, Inc. JPZ Class I 1988-05-31
K881803 UVMAX KINETIC MICROPLATE READER Molecular Devices Corp. JJQ Class I 1988-05-31
K881229 AUTO TROL(TM) CONTROL, LEVELS 1 & 2 #16692 & 16693 Em Diagnostic Systems, Inc. JJY Class I 1988-05-27
K880308 CALCIUM Catachem, Inc. CIC Class II 1988-05-27
K881258 PARAMAX ALCOHOL AND AMMONIA CALIBRATOR, I & II Baxter Healthcare Corp JIX Class II 1988-05-27
K881596 FSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1057 Medix Biotech, Inc. CGJ Class I 1988-05-27
K881595 QUIDEL PREGNANCY TEST Quidel Corp. JHI Class II 1988-05-27
K881357 EMIT CONVENIENCE PACK: THYROXINE ASSAY Syva Co. KLI Class II 1988-05-27
K881241 TOTAL BILIRUBIN REAGENT Tech-Neal Scientific, Inc. CIG Class II 1988-05-27
K881702 BIOTROL TRIGLYCERIDES ENZYMATIQUE UV H.P. Biotrol, USA, Inc. CDT Class I 1988-05-27
K875029 ABBOTT BREATH ACETONE ANALYZER Abbott Laboratories JIN Class I 1988-05-27
K881326 HDL CHOLESTEROL PRECIPITATING PROCEDURE Data Medical Associates, Inc. LBR Class I 1988-05-27
K881626 GAMMA-GLUTAMYL TRANSFERASE Tech-Co, Inc. JQB Class I 1988-05-27
K881443 LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUNO. ASSAY London Diagnostics, Inc. JLW Class II 1988-05-27
K881005 IMMUCHEM HUMAN CHORIONIC GONADOTROPIN HORMONE HCG Icn Biomedicals, Inc. JHI Class II 1988-05-27
K881214 IMMPULSE T, ASSAY REAGENTS Sclavo, Inc. CDP Class II 1988-05-27
K881435 PREGNOSPIA II Organon Teknika Corp. JHJ Class II 1988-05-27
K880917 LYTENING 5 Amdev, Inc. JGS Class II 1988-05-27
K880692 ASPARTATE AMINOTRANSFERASE ASSAY KIT (IFCC) Diagnostic Chemicals, Ltd. (Usa) CIT Class II 1988-05-27
K881655 SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE CONTROL Biomedical Research & Development Laboratories, Inc. JJR Class I 1988-05-27
K881440 IQ POTASSIUM Bd Becton Dickinson Vacutainer Systems Preanalytic CEJ Class II 1988-05-27
K874027 LIPASE UV [TOYO] Advocacy International, Ltd. CHI Class I 1988-05-27
K880724 LIQUID CHROMATO. COLUMNS Supelco, Inc. DPM Class I 1988-05-27
K881373 AMERLITE TT3 ASSAY, LAN.0003/2003 240/144 KIT Amersham Corp. CDP Class II 1988-05-27
K880880 RAICHEM(TM) MAGNESIUM REAGENT, ENZYMATIC Reagents Applications, Inc. JGJ Class I 1988-05-27
K880447 MULTI-FUNCTION BLOOD GAS CONTROL Bionostics, Inc. JJY Class I 1988-05-27
K863395 WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZER Wescor, Inc. CGZ Class II 1988-05-24
K881300 MAGNESIUM LIQUID STABLE REAGENT SET Medical Analysis Systems, Inc. JGJ Class I 1988-05-17
K880163 PREGNANCY (HCG) CARD & LIQUID TEST Ampcor, Inc. JHJ Class II 1988-05-17
K881201 HR VACUTRAC Icu Medical, Inc. JKA Class II 1988-05-16
K881275 URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II Fisher Scientific Co., LLC JJY Class I 1988-05-16
K881255 NOVA 12 NA/K/C1/TOTAL CARBON DIOXIDE/GLUCOSE/UREA Nova Biomedical Corp. JGS Class II 1988-05-16
K880472 ADVANCE* AND DAISY* PREGNANCY TEST Advanced Care Products LCX Class II 1988-05-16
K881267 BIOTROL CK MONOEACTIF Biotrol, USA, Inc. JHX Class II 1988-05-16
K881366 BIOTROL BUN ENZYMATIQUE UV H.P. Biotrol, USA, Inc. CDQ Class II 1988-05-16
K873577 GEM-STAT, GEM-PAK 2, GEM-CHECK, GEM-CRIT CHECK Diamond Sensor Systems CHL Class II 1988-04-28
K874909 MICRO-BUMINTEST REAGENT TABLETS Miles Laboratories, Inc. JIR Class I 1988-04-28
K881400 CREATININE FOR CONTINUOUS FLOW INSTRUMENTS Catachem, Inc. CGX Class II 1988-04-28
K881311 BIOTROL -GT GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST Biotrol, USA, Inc. JQB Class I 1988-04-28
K881204 ACP KINETIC TEST (ACID PHOSPHATASE TEST) Sclavo, Inc. CKB Class II 1988-04-28
K881167 IRON PROCEDURE Data Medical Associates, Inc. JIY Class I 1988-04-28
K881166 DIRECT BILIRUBIN PROCEDURE Data Medical Associates, Inc. CIG Class II 1988-04-28
K881240 CHLORIDE REAGENT SET Tech-Neal Scientific, Inc. CHJ Class II 1988-04-28
K880866 CARBON DIOXIDE ASSAY KIT(ENZY. SINGLE) 203-10 Diagnostic Chemicals, Ltd. (Usa) KHS Class II 1988-04-28
K881200 CHLORIDE LIQUID STABLE REAGENT SET Medical Analysis Systems, Inc. CHJ Class II 1988-04-28
K880237 CHOLESTEROL Tech-Neal Scientific, Inc. CHH Class I 1988-04-28
K880478 PREGNANCY BETA-HCG CARD & LIQUID TEST Ampcor, Inc. JHJ Class II 1988-04-28
K880594 VACUGUARD(TM) Habley Medical Technology Corp. JKA Class II 1988-04-28
K880967 MICRO CO2 APPARATUS Hf Scientific, Inc. CIE Class II 1988-04-28
K881171 PHOSPHORUS (INORGANIC) Tech-Co, Inc. CEO Class I 1988-04-28
K881169 CARBON DIOXIDE REAGENT Intersect Systems, Inc. KHS Class II 1988-04-28
K881202 IRON TEST Sclavo, Inc. JIY Class I 1988-04-28
K881123 ALLEGRO(TM) FOLLICLE STIMULATING HORMONE IMMUNO. Nichols Institute Diagnostics CGJ Class I 1988-04-28
K881237 CREATINE KINASE (CK) REAGENT SET Tech-Neal Scientific, Inc. JHX Class II 1988-04-28
K881104 PARAMAX IRON REAGENT Baxter Healthcare Corp JIY Class I 1988-04-28
K881433 HEART CHECK APOLIPOPROTEIN-B Northwest Biotech MSJ Class I 1988-04-21
K881434 HEART CHECK APOLIPOPROTEIN A-1 Northwest Biotech MSJ Class I 1988-04-21
K880867 AMYLASE 405 CATALOG NUMBER 301-34 Diagnostic Chemicals, Ltd. (Usa) JFJ Class II 1988-04-19
K880087 ABBOTT IMX T3 Abbott Laboratories CDP Class II 1988-04-18
K875207 ALBUMIN CAT. # 201-03 Diagnostic Chemicals, Ltd. (Usa) CIX Class II 1988-04-18
K875208 CHLORIDE CAT. # 152-17 Diagnostic Chemicals, Ltd. (Usa) CHJ Class II 1988-04-18
K880585 DEXPAD, BLOOD GLUCOSE STRIP Mach Diag. C/O Wichita State University CGA Class II 1988-04-18
K880619 EMIT T-UPTAKE ASSAY THYROID HORMONE BINDING RATIO Syva Co. KHQ Class II 1988-04-18
K880622 LABCO LIMITED EXETAINER(R) Labco, Ltd. JKA Class II 1988-04-18
K881124 ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY Nichols Institute Diagnostics CEP Class I 1988-04-18
K880758 SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY Boots-Celltech Diagnostics, Inc. CEP Class I 1988-04-18
K875211 GLUCOSE (TRINDER) CAT. # 220-32 Diagnostic Chemicals, Ltd. (Usa) CGA Class II 1988-04-18
K880798 ACID PHOSPHATASE REAGENT Trace America, Inc. CKB Class II 1988-04-18
K880794 RESUBMITTED BICARBONATE (CO2) REAGENT SINGLE VIAL Trace America, Inc. KHS Class II 1988-04-18
K881054 CALCIUM, CATALOGUE NUMBER 122-20 Diagnostic Chemicals, Ltd. (Usa) CIC Class II 1988-04-18
K880796 ALKALINE PHOSPHATASE REAGENT, DEA BUFF Trace America, Inc. CJE Class II 1988-04-18
K880795 RESUBMITTED ALKALINE PHOSPHATASE REAGENT AMP BUFF. Trace America, Inc. CJE Class II 1988-04-18
K880277 URIC ACID REAGENT SET Tech-Neal Scientific, Inc. KNK Class I 1988-04-18
K880934 MODIFIED AMERLEX-M PROGESTERONE RADIOIMMUNO. KIT Amersham Corp. JLS Class I 1988-04-18
K872889 ROMEO(TM) MODEL 1000 Diva Medical Systems, Inc. CGA Class II 1988-04-13
K880086 ABBOTT IMX HTSH Abbott Laboratories JLW Class II 1988-04-05
K880678 MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAY Ventrex Laboratories, Inc. DHA Class II 1988-04-05
K880743 ABBOTT A-GENT NEONATAL BILIRUBIN REAGENT Abbott Laboratories CIG Class II 1988-04-05
K880844 ALBUMIN REAGENT SET Tech-Neal Scientific, Inc. CIX Class II 1988-04-05
K874823 FIRST RESPONSE 5 MINUTE PREGNANCY TEST Tambrands, Inc. LCX Class II 1988-04-05
K880845 CALCIUM REAGENT SET Tech-Neal Scientific, Inc. CIC Class II 1988-04-05
K880177 ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHAT Tech-Co, Inc. CIO Class II 1988-04-05
K880842 LDH-L REAGENT SET Tech-Neal Scientific, Inc. CFJ Class II 1988-04-05
K881254 STATSPIN DISPOSABLE ROTOR, PRODUCT #RD01 Norfolk Scientific, Inc. JQC Class I 1988-04-05
K880949 SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER Advanced Biomedical Methods, Inc. CJY Class II 1988-04-05
K880410 HUMAN CHORIONIC GONADOTROPIN VISUAL TEST KIT Disease Detection International, Inc. JHI Class II 1988-04-05
K880843 CREATININE REAGENT SET (KINETIC) Tech-Neal Scientific, Inc. CGX Class II 1988-04-05
K875079 MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE Miles Laboratories, Inc. CKA Class I 1988-04-05
K880731 WAKO AUTOKIT URIC ACID Wako Chemicals USA, Inc. KNK Class I 1988-03-24
K880070 ABBOTT IMX HCG Abbott Laboratories JHI Class II 1988-03-24
K874875 CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA) Boots-Celltech Diagnostics, Inc. CEC Class II 1988-03-24
K880687 CORTISOL ENHANCED LUMINESCENCE ASSAY KIT Amersham Corp. CGR Class II 1988-03-24
K880676 INORGANIC PHOSPHORUS REAGENT SET Tech-Neal Scientific, Inc. CEO Class I 1988-03-24
K880312 WAKO(TM) AUTOKIT TOTAL PROTEIN Wako Chemicals USA, Inc. CEK Class II 1988-03-24

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