meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
60
Latest Decision
1986-04-28

Clearances · page 89 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K861448 QUANTIMETRIX SERUM LIPID CONTROL I & II LIQUID Quantimetrix Medical Industries JJY Class I 1986-04-28
K861283 AST REAGENT CARTRIDGE Hi Chem, Inc. CIT Class II 1986-04-28
K860900 IMMPULSE FREE ESTRIOL ASSAY REAGENTS Sclavo, Inc. CGI Class I 1986-04-28
K861231 ALT REAGENT CARTRIDGE (PRODUCT NO. 88210) Hi Chem, Inc. CKA Class I 1986-04-28
K861284 AP REAGENT CARTRIDGE Hi Chem, Inc. CJE Class II 1986-04-28
K860824 TSHK-NN RIA KIT Cis-Us, Inc. JLW Class II 1986-04-28
K861311 GLUCOSE (HEXOKINASE) REAGENT SET Sterling Diagnostics, Inc. CFR Class II 1986-04-24
K860715 ALP (ALKALINE PHOSPHATASE) REAGENT Trace Scientific , Ltd. CJE Class II 1986-04-24
K860733 CK-NAC REAGENT CREATINE KINASE N-ACETYL CYSTEINE Trace Scientific , Ltd. CGS Class II 1986-04-24
K861194 ULTROSPEC K KINETICS SPECTROPHOTOMETER Lkb Instruments, Inc. JJQ Class I 1986-04-24
K861055 EASY-TEST ISE CALIBRATOR, ITEM NO. 67566/95 Em Diagnostic Systems, Inc. JJE Class I 1986-04-24
K860716 ENZYMATIC BUN REAGENT Trace Scientific , Ltd. CDQ Class II 1986-04-24
K860713 LACTATE DEHYDROGENASE (LD) FOR CONT. FLOW INSTRUM. Catachem, Inc. CFJ Class II 1986-04-24
K861204 GLUCOSE OXIDASE PROCEDURE Data Medical Associates, Inc. CGA Class II 1986-04-24
K860965 BETA QUIK STICK Pacific Biotech, Inc. JHI Class II 1986-04-24
K861061 EMDS CREATINE KINASE ISOENZYME CKMB TEST PACK Em Diagnostic Systems, Inc. CGS Class II 1986-04-24
K860335 COAT-A-COUNT 17-ALPHA-HYDROXYPROGESTERONE RIA KIT Diagnostic Products Corp. JLX Class I 1986-04-24
K861320 MMS T4 RIA KIT Micromedic Systems CDX Class II 1986-04-24
K861168 CLEARBLUE PREGNANCY TESTING KIT Unipath , Ltd. LCX Class II 1986-04-24
K861221 EASY-TEST CHEK (INSTRUM. CHECK) & EMDS ABS TEST Em Diagnostic Systems, Inc. JJX Class I 1986-04-24
K861413 BILIRUBIN*SR (TOTAL) LIQUID STABLE REAGENT SET Medical Analysis Systems, Inc. CIG Class II 1986-04-24
K860334 VISI-CHECK HLH TEST MONOCLONAL Bioclinical Systems, Inc. CEP Class I 1986-04-21
K860726 ENZYMATIC GLUCOSE REAGENT SINGLE VIAL GLUCOSE OXID Trace Scientific , Ltd. LFR Class II 1986-04-21
K860333 MICRO-ELISA HLH TEST KIT MONOCLONAL Bioclinical Systems, Inc. CEP Class I 1986-04-21
K861002 VISION SGPT (ALT) Abbott Laboratories CKA Class I 1986-04-21
K860451 MUREX (TM), SUDS (TM), HCG ASSAY Murex Corp. LCX Class II 1986-04-21
K861095 BILIRUBIN ASSAY KIT (TOTAL), CATA. NUMBER 202-04 Diagnostic Chemicals, Ltd. (Usa) CIG Class II 1986-04-21
K860543 BLOOD UREA NITROGEN (BUN) TESTCARD Ilex Corp. CDS Class II 1986-04-21
K860639 IONIZED CALCIUM AND BLOOD PH TESTCARDS Ilex Corp. JFP Class II 1986-04-21
K861094 BILIRUBIN ASSAY KIT (DIRECT), CATA. NUMBER 202-02 Diagnostic Chemicals, Ltd. (Usa) CIG Class II 1986-04-21
K860748 HITACHI 736 Boehringer Mannheim Corp. JJE Class I 1986-04-17
K860647 ES600 IMMUNOASSAY SYSTEM Boehringer Mannheim Corp. JJE Class I 1986-04-17
K860732 ENZYMATIC URIC ACID REAGENT Trace Scientific , Ltd. KNK Class I 1986-04-16
K860747 DU PONT SORVALL CENTRIFUGES (RAPIDSPIN R) E.I. Dupont DE Nemours & Co., Inc. JQC Class I 1986-04-14
K860288 ECHOCLONAL HTSH IRMA Bio-Rad JLW Class II 1986-04-11
K860367 MAGNESIUM (SUBSTRATE, ENZYME, REAGENT) Alpkem Corp. JGF Class II 1986-04-11
K860663 AMRESCO FLOW PAC CREATINE PHOSPHOKINASE REAGENT Amresco, Inc. JHY Class II 1986-04-11
K860090 ANSWER PLUS AT HOME PREGNANCY TEST Armkel, LLC LCX Class II 1986-04-11
K860717 ENZYMATIC CHOLESTEROL REAGENT (SINGLE VIAL) Trace Scientific , Ltd. CHH Class I 1986-04-11
K860422 STRAT THYROID UPTAKE FLUROMET ENZYME IMMUNOASSAY American Dade KHQ Class II 1986-04-11
K860640 EASY-TEST (GGT) REAGENT, ITEM NO. 67526/93 Em Diagnostic Systems, Inc. JQB Class I 1986-04-09
K860917 EASY-TEST TOTAL PROTEIN (TP), #67513/93 Em Diagnostic Systems, Inc. CEK Class II 1986-04-07
K860764 EMDS ENZYME VERIFIER, LEVELS I & II Em Diagnostic Systems, Inc. JJT Class I 1986-04-07
K860916 EASY-TEST URIC ACID (URIC), #67516/93 Em Diagnostic Systems, Inc. KNK Class I 1986-04-07
K851338 DOUBLE ANTIBODY ALBUMIN FOR DETECT MICROALBUMINURI Diagnostic Products Corp. JIR Class I 1986-04-07
K860728 L D H-L (LACTIC DEHYDROGENASE) REAGENT Trace Scientific , Ltd. CFJ Class II 1986-04-07
K860725 AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT Trace Scientific , Ltd. CIT Class II 1986-04-07
K860765 EMDS CHEMISTRY CALIBRATORS, LEVELS I & II Em Diagnostic Systems, Inc. JIX Class II 1986-04-07
K861068 GILFORD UNIQUAL NORMAL CONTROL SERUM - ASSAYED Ciba Corning Diagnostics Corp. JJY Class I 1986-04-07
K860669 CREATINE KINASE, N-ACETYL-L-CYSTIENE Em Diagnostic Systems, Inc. CGS Class II 1986-04-07
K860501 FLAME PHOTOMETER STANDARD Medical Specialties, Inc. JLJ Class II 1986-04-07
K860723 G.T. (GAMMA-GLUTAMYL TRANSFERASE) REAGENT Trace Scientific , Ltd. JPZ Class I 1986-04-07
K860731 TRIGLYCERIDES REAGENT (INT, COLORIMETRIC) Trace Scientific , Ltd. JGY Class I 1986-04-07
K860730 ENZYMATIC TRIGLYCERIDES REAGENT (SINGLE VIAL) Trace Scientific , Ltd. CDT Class I 1986-04-07
K860724 ENZYMATIC GLUCOSE REAGENT (HEXOKINASE) Trace Scientific , Ltd. CFR Class II 1986-04-07
K860668 ION-SPECIFIC ELECTRODE, CHLORIDE Em Diagnostic Systems, Inc. CGZ Class II 1986-04-07
K861087 AVL MODEL 983 ELECTROLYTE ANALYZER Avl Scientific Corp. JGS Class II 1986-04-07
K860665 ALPHA-AMYLASE TEST Sclavo, Inc. JFJ Class II 1986-04-07
K860311 ACTHK-PR RIA KIT Compagnie Oris Industrie, S.A. CKG Class II 1986-04-07
K860727 ALT(GPT) (ALANINE AMINOTRANSFERASE) REAGENT Trace Scientific , Ltd. CKA Class I 1986-04-07
K860729 LDH-P (LACTIC DEHYDROGENASE) REAGENT Trace Scientific , Ltd. CFJ Class II 1986-04-07
K855024 MARQUEST QC-IV TONOMETER Marquest Medical Products, Inc. JJS Class I 1986-04-07
K854223 VES-TEC/VES-MATIC Marvic Interpharma, Inc. CKB Class II 1986-04-04
K860485 SGPT (ALT) REAGENT SET (COLORIMETRIC) Sterling Diagnostics, Inc. CKD Class I 1986-04-03
K860970 PRECINORM IM AND PRECIPATH IM Boehringer Mannheim Corp. JJY Class I 1986-04-03
K860426 A-GENT LIQUID TOTAL PROTEIN Abbott Laboratories CEK Class II 1986-04-03
K860667 ASPARTATE AMINOTRANSFERASE (AST/SGOT) REAGENT SET Sterling Diagnostics, Inc. CIT Class II 1986-04-03
K860477 URIC ACID REAGNET SET (TRINDER) Sterling Diagnostics, Inc. KNK Class I 1986-04-03
K860425 A-GENT LIQUID CALCIUM Abbott Laboratories CIC Class II 1986-04-03
K860424 A-GENT LIQUID TOTAL BILIRUBIN Abbott Laboratories CIG Class II 1986-04-03
K860216 SGOT (AST) REAGENT SET Sterling Diagnostics, Inc. CIQ Class II 1986-04-03
K860799 ANALYTE IRON/TECHNICON CHEM 1 SYSTEM Technicon Instruments Corp. JIY Class I 1986-04-03
K861000 GILFORD UNIQUAL NORMAL CONTROL SERUM/UNASSAYED Ciba Corning Diagnostics Corp. JJY Class I 1986-04-03
K860918 EASY-TEST AMLASE (AMYL), #67521/93 Em Diagnostic Systems, Inc. JFJ Class II 1986-04-03
K860998 GILFORD UNIQUAL ABNORMAL CONTROL SERUM/UNASSAYED Ciba Corning Diagnostics Corp. JJY Class I 1986-04-03
K860629 BIOGRAM APO A1/B Bio-Rad MSJ Class I 1986-03-28
K854265 SIMULATOR Cygnus of South Florida, Inc. JQP Class I 1986-03-18
K860348 GAMMA GLUTAMYL TRANSPEPTIDASE (GGTP) REAGENT SET Sterling Diagnostics, Inc. JPZ Class I 1986-03-17
K860054 TSH-IRMA COAT-A-COUNT KIT Diagnostic Products Corp. JLW Class II 1986-03-17
K860308 SUCROSEP LUTEINIZING HORMONE (LH) IRMA Boots-Celltech Diagnostics, Inc. CEP Class I 1986-03-17
K860625 GLUCOSE HK-60 ASSAY KIT CAT. #201-39 Diagnostic Chemicals, Ltd. (Usa) CFR Class II 1986-03-17
K860423 A-GENT LIQUID ALBUMIN Abbott Laboratories CJW Class II 1986-03-17
K855036 CHEMISTRY CONTROL N & A Integrated Medical Systems Int'L., Inc. JJY Class I 1986-03-17
K860355 BOVINE CHEMISTRY CONTROL I.X AND II.X American Dade JJY Class I 1986-03-17
K860690 TRIGLYCERIDES FOR CONTINUOUS FLOW INSTRUMENTS Catachem, Inc. CDT Class I 1986-03-17
K860214 TOTAL BILIRUBIN REAGENT SET Sterling Diagnostics, Inc. CIG Class II 1986-03-17
K854876 ALDOSTERONE DIRECT RIA KIT Biotecx Laboratories, Inc. KQN Class II 1986-03-17
K855035 CALIBRATION REFERENCE I & II Integrated Medical Systems Int'L., Inc. JJY Class I 1986-03-17
K860684 SANDARE BCG ALBUMIN PROCEDURE Sandare Chemical Co., Inc. CIX Class II 1986-03-17
K860197 SERIES 410 LC PUMP The Perkin-Elmer Corp. KZR Class I 1986-03-17
K860003 LEECO TESTOSTERONE DIAGNOSTIC KIT Leeco Diagnostics, Inc. CDZ Class I 1986-03-17
K860554 SERUM LIPASE REAGENT SET (TURBIDIMETRIC) Sterling Diagnostics, Inc. CFG Class I 1986-03-14
K860478 SERUM IRON & IRON BINDING REAGENT SET Sterling Diagnostics, Inc. JIY Class I 1986-03-14
K860245 ENZYMATIC ALPHA-AMYLASE REAGENT KIT Bio-Analytics Laboratories, Inc. JFJ Class II 1986-03-14
K855214 CAT-3 CATECHOLAMINE ASSAY KIT Whale Scientific, Inc. CHQ Class I 1986-03-14
K860661 AMRESCO FLOW PAC ALBUMIN BROMOCRESOL GREEN REAGENT Amresco, Inc. CIX Class II 1986-03-14
K860628 INORGANIC PHOSPHORUS REAGENT SET Sterling Diagnostics, Inc. CEO Class I 1986-03-14
K860662 AMRESCO FLOW PAC CHLORIDE REAGENT NO. 2256 & 2271 Amresco, Inc. CHJ Class II 1986-03-14
K860660 AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS Amresco, Inc. CHS Class II 1986-03-14
K855014 QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A Kallestad Laboratories, Inc. JIX Class II 1986-03-14

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