meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
50
Latest Decision
1987-06-03

Clearances · page 83 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K870095 BILIRUBIN TESTER Wako Chemicals USA, Inc. CIG Class II 1987-06-03
K871397 ANALYZER: NOVA STAT PROFILE 3 ANALYZER Nova Biomedical Corp. CHL Class II 1987-06-03
K871781 ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SET Biochemical Trade, Inc. CFJ Class II 1987-06-03
K870890 ALKALINE PHOSPHATASE INDOLYL BLUE REAGENT Helena Laboratories CIN Class II 1987-06-01
K870746 STANBIO ALPHA-AMYLASE TEST SET, CATALOG 0180-715 Stanbio Laboratory JFJ Class II 1987-06-01
K870627 AFFINITY (TM) HCG IMMUNIT (TM) Bd Becton Dickinson Vacutainer Systems Preanalytic JHI Class II 1987-05-28
K871028 CIBA CORNING MODEL 664/FAST 4 SYSTEM Ciba Corning Diagnostics Corp. JGS Class II 1987-05-28
K871182 FLAME PHOTOMETER STANDARD #60081 120 NA/2K In Vitro Diagnostics, Inc. JIX Class II 1987-05-28
K871187 LITHIUM INTERNAL STANDARD 3000 MEQ/L #60084 In Vitro Diagnostics, Inc. JIS Class II 1987-05-28
K871183 FLAME PHOTOMETER STANDARD #60082 140 NA/5K In Vitro Diagnostics, Inc. JIX Class II 1987-05-28
K871185 LITHIUM INTERNAL STANDARD 1 MEQ/L #60085 In Vitro Diagnostics, Inc. JIS Class II 1987-05-28
K871186 CESIUM DILUENT 1.5 MMOL CS/L #60087 In Vitro Diagnostics, Inc. JIS Class II 1987-05-28
K871188 LITHIUM INTERNAL STANDARD 1500 MEQ/L #60086 In Vitro Diagnostics, Inc. JIS Class II 1987-05-28
K871184 FLAME PHOTOMETER STANDARD #60083 160 NA/8K In Vitro Diagnostics, Inc. JIX Class II 1987-05-28
K871756 CREATININE STANDARD SOLUTION CALIBRATOR Wako Chemicals USA, Inc. JIT Class II 1987-05-27
K871782 ULTRAVIOLET ALANINE AMINO-TRANS (UV-ALT/UV-GPT) Biochemical Trade, Inc. CKA Class I 1987-05-26
K871765 PHOSPHOLIPIDS STANDARD SOLUTION CALIBRATOR Wako Chemicals USA, Inc. JIT Class II 1987-05-26
K871874 CIBA CORNING MAGIC LITE ANALYZER II Ciba Corning Diagnostics Corp. JJQ Class I 1987-05-26
K871766 TRIGLYCERIDE STANDARD SOLUTION CALIBRATOR Wako Chemicals USA, Inc. JIT Class II 1987-05-26
K871811 SYSTEM REAGENTS HITACHI 737 CALCIUM (EDTA) Boehringer Mannheim Corp. CIC Class II 1987-05-26
K871764 INORGANIC PHOSPHOROUS STANDARD SOLUTION CALIBRATOR Wako Chemicals USA, Inc. JIT Class II 1987-05-26
K871767 UREA N STANDARD SOLUTION CALIBRATOR Wako Chemicals USA, Inc. JIT Class II 1987-05-26
K871763 NEFA STANDARD SOLUTION CALIBRATOR Wako Chemicals USA, Inc. JIT Class II 1987-05-26
K871838 BIOMEK 1000C AUTOMATED LABORATORY WORK STATION Beckman Instruments, Inc. JJG Class I 1987-05-26
K871768 URIC ACID STANDARD SOLUTION CALIBRATOR Wako Chemicals USA, Inc. JIT Class II 1987-05-26
K871758 GLUCOSE STANDARD SOLUTION CALIBRATOR Wako Chemicals USA, Inc. JIT Class II 1987-05-26
K871762 MAGNESIUM STANDARD SOLUTION CALIBRATOR Wako Chemicals USA, Inc. JIT Class II 1987-05-26
K871307 SYVA Q-SPEC PHOTOMETER Syva Co. JJQ Class I 1987-05-26
K870904 MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KIT Micromedic Systems JLW Class II 1987-05-26
K870998 TECHNICON RA-XT(TM) SYSTEM IMMUNOASSAYS Technicon Instruments Corp. JJC Class I 1987-05-26
K871505 AUTOPAK NEONATAL TSH MONOCLONAL IRMA KIT Micromedic Systems JLW Class II 1987-05-26
K871008 MICROMEDIC NEONATAL T4 KIT Micromedic Systems CDX Class II 1987-05-26
K871150 ASTRA(TM) SYSTEMS TRIGLYCERIDES CALIBRATOR 8 Beckman Instruments, Inc. JIT Class II 1987-05-26
K870987 CIBA CORNING MAGIC(R) LITE CKMB IMMUNOASSAY Ciba Corning Diagnostics Corp. JHX Class II 1987-05-26
K864282 GLUCOSE TESTCARD USE W/ILEX PROMPT CLINICAL CH ANA Medical Device Consultants, Inc. CGA Class II 1987-05-26
K871341 QM300 CALIBRATOR A PACK Kallestad Diag, A Div. of Erbamont, Inc. JIX Class II 1987-05-21
K871342 QM2/QM300 CONTROL A PACK Kallestad Diag, A Div. of Erbamont, Inc. JJY Class I 1987-05-21
K870739 ABBOTT TESTPACK HCG COMBO Abbott Laboratories JHI Class II 1987-05-20
K870751 SYNTRON BIORESEARCH EZ CHECK HCG PREGNANCY TEST Syntron Bioresearch, Inc. JHI Class II 1987-05-20
K871317 FOLLICLE STIMULATING HORMONE (HFSH) Immuchem Corp. CGJ Class I 1987-05-20
K871687 TYTEM(R) REAGENT DISPENSER Medical Laboratory Automation Systems, Inc. JQW Class I 1987-05-20
K871531 REAGENTS 1263,1273,1284,1425,014301,053583 American Research Products Co. CIG Class II 1987-05-18
K871676 ENZYMATIC CHOLESTEROL REAGENT SET Michclone Associates, Inc. CHH Class I 1987-05-18
K871339 KALLESTAD QM300 PROTEIN ANALYSIS SYSTEM Kallestad Diag, A Div. of Erbamont, Inc. JQP Class I 1987-05-15
K871461 VISION (TM) HDL CHOLESTEROL Abbott Laboratories LBS Class I 1987-05-14
K871542 HPROLACTIN KIT Immuchem Corp. CFT Class I 1987-05-14
K870965 CIBA CORNING MAGIC(R) LITE T4 IMMUNOASSAY Ciba Corning Diagnostics Corp. CDX Class II 1987-05-14
K871530 TOTAL BILIRUBIN REAGENT 1372,1425,1284,1273,053583 American Research Products Co. CIG Class II 1987-05-14
K871240 ABBOTT A-GENT LD-1 ISOZYME REAGENT Abbott Laboratories JGF Class II 1987-05-13
K871644 DELFIA (TM) HTSH KIT Lkb Instruments, Inc. JLW Class II 1987-05-12
K871677 CREATINE KINASE FOR CONTINUOUS FLOW INSTRUMENTS Catachem, Inc. JHY Class II 1987-05-12
K870035 KODAK EKTACHEM DT SLIDES (CA) Eastman Kodak Company CID Class II 1987-05-12
K870183 IONOMETER EF AND ACCESSORIES Smash Ent., Inc. JGS Class II 1987-05-12
K871638 EASY-TEST CHEM CAL LEVELS 1,2&3/ITEMS 67617 ABC/95 Em Diagnostic Systems, Inc. JIX Class II 1987-05-12
K870657 AVL MODEL 985 ELECTROLYTE ANALYZER Avl Scientific Corp. CEM Class II 1987-05-12
K871650 GLUCOSE ENZYME - COLOR REAGENT SET Biochemical Trade, Inc. CGA Class II 1987-05-12
K871651 COLORIMETRIC BUN REAGENT KIT Biochemical Trade, Inc. CDL Class II 1987-05-12
K871294 ACU-PREG-AL SLIDE TEST Papibris Scientific, Inc. JHJ Class II 1987-05-12
K871509 RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL) Trace Scientific , Ltd. CDT Class I 1987-05-08
K871664 IRON & MAGNESIUM ADDITIONS/REFERRIL B CALIBRATOR Instrumentation Laboratory CO JIX Class II 1987-05-08
K871508 RESUBMITTED TRIGLYCERIDE GPO - TWO VIAL Trace Scientific , Ltd. CDT Class I 1987-05-08
K871486 (FPIA) ASSAY BUFFER Windsor Laboratories, Inc. JJF Class I 1987-05-08
K871537 CANTROL HDL CHOLESTROL CONTROLS LEVELS I AND II Canyon Diagnostics, Inc. JJY Class I 1987-05-06
K870958 TITAN GEL MULTI-SLOT SP-17 KIT CAT. NO. 3091 Helena Laboratories CEF Class I 1987-04-29
K870629 CALCIUM TEST Sclavo, Inc. CIC Class II 1987-04-29
K871456 ULTRA-VIOLET GLUCOSE REAGENT KIT Biochemical Trade, Inc. CFR Class II 1987-04-29
K871414 EMDS TIBC PRETREATMENT SET ITEM NO. 67612/93 Em Diagnostic Systems, Inc. JMO Class I 1987-04-23
K870630 CHLORIDE TEST Sclavo, Inc. CHJ Class II 1987-04-22
K870928 CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS Electro-Nucleonics Laboratories, Inc. CHH Class I 1987-04-22
K871417 COLORIMETRIC URIC ACID REAGENT SET Biochemical Trade, Inc. KNK Class I 1987-04-22
K871301 ENZYMATIC TRIGLYCERIDES GPO-TRINDER METHOD American Monitor Corp. CDT Class I 1987-04-22
K871319 TITAN GEL MULTI-SLOT LIPO-17 SYSTEM Helena Laboratories JHO Class I 1987-04-22
K871320 FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814 American Research Products Co. CDW Class II 1987-04-22
K871415 MICROPLATE LUMINOMETER ML 1000 (NO. 012-101-000) Dynatech Laboratories, Inc. JJQ Class I 1987-04-22
K871321 FLOW-PAC INORGANIC PHOSPHORUS REAGENTS American Research Products Co. CEO Class I 1987-04-22
K870573 T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT Cambridge Medical Technology CDX Class II 1987-04-22
K870544 BIOMEK 1000 AUTOMATED LABORATORY WORK STATION Beckman Instruments, Inc. JQW Class I 1987-04-22
K870949 WATERS 650 ADVANCED PROTEIN PURIFICATION SYSTEM Millipore Corp. LDM Class I 1987-04-22
K870752 SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS Miles Laboratories, Inc. CFJ Class II 1987-04-14
K871211 PROGESTERONE CLASP RADIOIMMUNOASSAY KIT Biotecx Laboratories, Inc. JLS Class I 1987-04-13
K870986 LIQUID-STAT IRON REAGENT KIT & TIBC REAGENT KIT Beckman Instruments, Inc. JIY Class I 1987-04-13
K870737 U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL U. S. Diagnostics, Inc. JJT Class I 1987-04-13
K871260 CHOLESTEROL DETERMINATION Biochemical Trade, Inc. CHH Class I 1987-04-13
K871269 RA SYSTEM, ANALYTE SERUM AMYLASE (30C AND 37C) Technicon Instruments Corp. JFJ Class II 1987-04-13
K864729 NEUROCHEMICAL ANALYZER Esa, Inc. LEQ Class I 1987-04-13
K870738 U.S. DIAGNOSTICS LIQUID CK ISOENZYME CONTROL U. S. Diagnostics, Inc. JJT Class I 1987-04-13
K871284 FLOW PAC TOTAL IRON REAGENTS:2183,2349,2312,014339 American Research Products Co. JIY Class I 1987-04-08
K870521 TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY Hybritech, Inc. JHI Class II 1987-04-08
K863481 MODIFICATION OF ACCU-CHEK II Boehringer Mannheim Corp. CGA Class II 1987-04-07
K871122 TRIGLYCERIDES DETERMINATION Biochemical Trade, Inc. CDT Class I 1987-04-07
K871058 SERACHEM LIQUID SPINAL FLUID CONTROL (HUMAN) Fisher Scientific Co., LLC JJY Class I 1987-04-06
K870683 LIQUID CHEMISTRY CONTROL, LEVEL II U. S. Diagnostics, Inc. JJY Class I 1987-04-06
K870684 LIQUID CHEMISTRY CONTROL, LEVEL I U. S. Diagnostics, Inc. JJY Class I 1987-04-06
K870245 AUTOPAK TSH MONOCLONAL IRMA KIT Micromedic Systems JLW Class II 1987-04-01
K870833 CIBA CORNING/SHIMADZU MODEL 580 CLINI. CHEM. ANALY Ciba Corning Diagnostics Corp. JJE Class I 1987-04-01
K870672 ACA HUMAN CHORIONIC GONADOTROPIN (HCG) METHOD E.I. Dupont DE Nemours & Co., Inc. JHI Class II 1987-04-01
K870836 ATAC 1500 CHEMISTRY ANALYZER Turpen Laboratory Systems, Inc. JJE Class I 1987-04-01
K870244 IQ TSH IMMUNOASSAY Bd Becton Dickinson Vacutainer Systems Preanalytic JLW Class II 1987-04-01
K870115 BERTHOLD LB 2103,2104-XT/PC/AT,951G GAMMA COUNTERS Berthold Analytical Instruments, Inc. JJJ Class I 1987-03-31
K870787 ABBOTT SPECTRUM AMMONIA REAGENT Abbott Laboratories JIF Class I 1987-03-31

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