meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
61
Latest Decision
1985-02-06

Clearances · page 95 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K850281 CALCIUM Boehringer Mannheim Corp. CIC Class II 1985-02-06
K850202 GELMAN TRIPHOR CONTROL Gelman Sciences, Inc. JJY Class I 1985-02-06
K850141 ACTIVE CORTISOL DSL 2000-SP Diagnostic Systems Laboratories, Inc. CGR Class II 1985-02-06
K844996 PARAGON TRICHECK ELECTROPHORESIS CONTROL Beckman Instruments, Inc. JJY Class I 1985-02-06
K844188 CORNING CALCIUM PH ANALYZER 634 Corning Medical & Scientific JFP Class II 1985-02-04
K850031 VISION TRIGLYCERIDES Abbott Laboratories CDT Class I 1985-02-04
K850128 SYSTE MATE TIBC HEM NO. 67225 Em Diagnostic Systems, Inc. JMO Class I 1985-02-01
K844781 MEMBRANE KITS-KC1, CO2 & 02 FOR INSTRUMENT-LAB Shaban Mfg. Co. CHL Class II 1985-02-01
K844767 RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO Biotecx Laboratories, Inc. CGI Class I 1985-02-01
K850008 SOPHEIA/MP CORTISOL EIA KIT Diagnostic Products Corp. CGR Class II 1985-02-01
K845026 AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT CODE Amersham Corp. JLS Class I 1985-02-01
K850110 VISION -FORMERLY PDA- ALKALINE PHOSPHATASE Abbott Laboratories CJE Class II 1985-01-29
K845020 SYSTE MATE IRON, HEM NO. 67224 Em Diagnostic Systems, Inc. JIY Class I 1985-01-28
K844347 FISHER DIAG. PREGNACLONE TUBE PREGNANCY TEST KIT Fisher Diagnostics JHJ Class II 1985-01-23
K844511 TDX TOTAL ESTRIOL Abbott Laboratories CGI Class I 1985-01-18
K844987 ROCHE REAGENTS REAGENT FOR CO2 Roche Diagnostic Systems, Inc. KHS Class II 1985-01-18
K844587 AVL MODEL 982 ELECTROLYTE ANALYZER Avl Scientific Corp. JGS Class II 1985-01-18
K844559 MODEL 1020 NA+/K+(SODIUM/POTASSIUM)ANALYZER MULTI Thermo Orion JGS Class II 1985-01-18
K844986 ROCHE REAGENTS REAGENT FOR URIC ACID Roche Diagnostic Systems, Inc. CDO Class I 1985-01-18
K844066 COTROPIN STIMULATANEOUS 57 CO-LH 125I I-FSH Clinetics Corp. CGJ Class I 1985-01-18
K844907 CLINIFACTS 10 DATA MANAGEMENT SYSTEM Miles Laboratories, Inc. JQP Class I 1985-01-18
K845027 KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES Eastman Kodak Company CHI Class I 1985-01-18
K845024 BAKER CKMB REAGENT SET Hybritech, Inc. JHY Class II 1985-01-18
K844998 GLUCOSE(HEXOKINASE) REAGENT SET Sterling Biochemical, Inc. CFR Class II 1985-01-18
K843382 UROCYSTIN Mission Pharmacal Co. JLC Class I 1985-01-08
K844125 LYPHOCHEK PREGNANCY CONTROL SERUM HUMAN Bio-Rad JJY Class I 1985-01-08
K844251 ALT/GPT REAGENT SET Sterling Biochemical, Inc. CKA Class I 1985-01-08
K844806 MODIFY ELECTROLYTE ANALYZER MODEL SERA-210 Horiba Instruments, Inc. CEM Class II 1985-01-08
K844709 CRITIC-ARS Dimension Diagnostics JIX Class II 1985-01-08
K844755 FOCUS UREA NITROGEN Abbott Laboratories CDQ Class II 1985-01-08
K844760 UROL-QUAL Dimension Diagnostics JJY Class I 1985-01-08
K844278 DATA-CHEM MAGNESIUM Data Medical Associates, Inc. JGJ Class I 1985-01-08
K844655 PERIDOCHROM CHOLESTEROL HIGH PERFORMANCE Boehringer Mannheim Corp. CHH Class I 1985-01-07
K844426 ALBUMIN BCP Boehringer Mannheim Corp. CJW Class II 1985-01-07
K844710 EUROCHIMA SERUM PROTEIN ELECTROPHORESIS METHOD Logos Scientific, Inc. JJN Class I 1985-01-07
K844798 EPPENDORF DILUTER Medical Technomics, Ltd. JQW Class I 1985-01-07
K844332 CREATININE REAGENT FOR DEMAND ANALYZER Advanced Biomedical Methods, Inc. CGX Class II 1985-01-03
K844241 CALCIUM REAGENT FOR DEMAND ANALYZER Advanced Biomedical Methods, Inc. CIC Class II 1985-01-03
K844242 CHOLESTEROL REAGENT FOR DEMAND ANALYZER Advanced Biomedical Methods, Inc. CHH Class I 1985-01-03
K844316 RAICHEM PHOSPHORUS REAGENT Reagents Applications, Inc. CEO Class I 1985-01-03
K844243 TOTAL BILIRUBIN FOR DEMAND ANALYZER Advanced Biomedical Methods, Inc. CIC Class II 1985-01-03
K844330 ALBUMIN REAGENT FOR DEMAND ANALYZER Advanced Biomedical Methods, Inc. CIX Class II 1985-01-03
K844344 GEMCAL ENI REFERENCE SERUM Biocell Laboratories, Inc. JIX Class II 1985-01-03
K843779 AUTOLOADER II Electro-Nucleonics Laboratories, Inc. JQW Class I 1985-01-03
K844331 TOTAL PROTEIN REAGENT FOR DEMAND ANALYZER Advanced Biomedical Methods, Inc. CEK Class II 1985-01-03
K843759 UROPAPER EIKEN HAG Syn-Kit, Inc. JIL Class II 1984-12-18
K843757 UROPAPER EIKEN AG Syn-Kit, Inc. JIL Class II 1984-12-18
K843754 UROPAPER EIKEN 7 Syn-Kit, Inc. JIL Class II 1984-12-18
K843760 UROPAPER EIKEN G Syn-Kit, Inc. JIL Class II 1984-12-18
K843753 UROPAPER EIKEN GP Syn-Kit, Inc. JIL Class II 1984-12-18
K843756 UROPAPER EIKEN 5 Syn-Kit, Inc. JIL Class II 1984-12-18
K843758 UROPAPER EIKEN GK Syn-Kit, Inc. JIL Class II 1984-12-18
K843755 UROPAPER EIKEN 6B Syn-Kit, Inc. JIL Class II 1984-12-18
K844153 CONCEP-7-BHCG (EIA) Leeco Diagnostics, Inc. JHI Class II 1984-12-14
K844581 80 MG/DL GLUCOSE CONTROL Boehringer Mannheim Corp. JIS Class II 1984-12-12
K844720 GGT PROCEDURE OR GAMMA GLUTAMYL TRANSFERASE PROCED Data Medical Associates, Inc. JQB Class I 1984-12-12
K844586 IL GENESIS 21, CLINICAL CHEMISTRY ANALYTICAL SYS Instrumentation Laboratory CO JJF Class I 1984-12-11
K844585 REFERRIL CALIBRATORS Instrumentation Laboratory CO JIX Class II 1984-12-11
K844408 AMERLEX-M SPECIFIC ESTRIOL UNCONJUGATED Amersham Corp. CGI Class I 1984-12-11
K842847 WAKO AUTOMATED REAGENTS FOR HITACHI 705 Wako Chemicals USA, Inc. CJW Class II 1984-12-11
K843284 OVUSTICK SELF-TEST Monoclonal Antibodies, Inc. CEP Class I 1984-12-11
K843530 CORNING 614 NA/K ANALYZER Corning Medical & Scientific JGS Class II 1984-12-11
K844468 TRIGLYCERIDE CALIBRATOR Sigma Diagnostics, Inc. JIT Class II 1984-12-11
K844281 PTK HEALTHCHECK PREGNANCY TEST KIT Healthcheck Corp. LCX Class II 1984-12-10
K844021 ISE REAGENTS FOR DEMAND ANALYZER Advanced Biomedical Methods, Inc. CGZ Class II 1984-12-10
K844398 COAT-A-COUNT ANDROSTENEDIONE RIA KIT Diagnostic Products Corp. CIZ Class I 1984-12-10
K844164 REACTIFS, IBF ULTROGELS ACA & ULTROGELS A Lkb Instruments, Inc. DII Class I 1984-12-10
K844498 SANDARE ALKALINE PHOSPHATASE PROCEDURE Sandare Chemical Co., Inc. CIO Class II 1984-12-10
K844295 ABL300 ACID BASE LABORATORY Radiometer America, Inc. CHL Class II 1984-12-10
K841545 ENZYME IMMUNOASSAY FOR DETECTION HORM Btc Diagnostics, Inc. CEP Class I 1984-11-27
K843453 ULTRA LYTE SODIUM REAGENT KIT Ultra Quest Diagnostics, Inc. JGS Class II 1984-11-27
K844027 SERACON TM SR III Bhp Diagnostix, Inc. JIX Class II 1984-11-27
K844114 ADD-1 Abbott Laboratories JJE Class I 1984-11-27
K843832 TRIGLYCERIDES REAGENT SYSTEM Fermco Biochemics, Inc. CDT Class I 1984-11-27
K844181 ACTH RIA Syncor Intl. Corp. CKG Class II 1984-11-27
K843914 COBAS FLUORESCENCE POLARIZATION MODULE Roche Diagnostic Systems, Inc. JJG Class I 1984-11-27
K843454 ULTRA LYTE POTASSIUM REAGENT KIT Ultra Quest Diagnostics, Inc. CEM Class II 1984-11-27
K844018 GAS TRAK BRAND CO-OXIMETER CONTROLS 1,2 & 3 United Diagnostics, Inc. JJY Class I 1984-11-27
K843986 STAT-TRAK PLUS LIQUID CHEMISTRY CONTROLS 1,2 & 3 United Diagnostics, Inc. JJY Class I 1984-11-27
K844026 SERACON TM SR IV Bhp Diagnostix, Inc. JIX Class II 1984-11-27
K844322 SGOT REAGENT SET Livonia Diagnostics, Inc. CIQ Class II 1984-11-27
K844044 LYTETEK 1000 NA/K SODIUM/POTASSIUM ANALYZER Medica Corp. CEM Class II 1984-11-27
K844283 SGPT REAGENT SET Livonia Diagnostics, Inc. CKD Class I 1984-11-27
K844065 ENI BLOOD UREA NITROGEN REAGENT Electro-Nucleonics Laboratories, Inc. CDQ Class II 1984-11-27
K844082 QUEST BETA HCG ENZYME IMMUNOASSAY KIT Quidel Corp. JHI Class II 1984-11-21
K844168 AMYLASE REAGENT CS-726 Fisher Scientific Co., LLC CJA Class II 1984-11-20
K844237 ALKALINE PHOSPHATASE REAGENT SET Livonia Diagnostics, Inc. CIO Class II 1984-11-20
K843568 LIQUID CHROMATOGRAPH 400 The Perkin-Elmer Corp. KZR Class I 1984-11-20
K844235 CHLORIDE STANDARD Shaban Mfg. Co. JIS Class II 1984-11-20
K843804 TANDEM - EPRL Hybritech, Inc. CFT Class I 1984-11-13
K844156 UREA NITROGEN REAGENT SET Livonia Diagnostics, Inc. CDW Class II 1984-11-13
K844182 INORGANIC PHOSPHORUS REAGENT SET Livonia Diagnostics, Inc. CEO Class I 1984-11-09
K844047 FISHER DIAGNOSTICS SERA CHEM SMAC CALIBRATORS Fisher Diagnostics JIT Class II 1984-11-09
K844032 TRIGLYCERIDE REAGENT Sigma Diagnostics, Inc. CDT Class I 1984-11-09
K842669 TITAN GEL ISO DOT LDH KIT Helena Laboratories CFE Class II 1984-11-09
K843109 ROCHE REAGENT FOR AST Roche Diagnostic Systems, Inc. CIT Class II 1984-11-05
K843894 HDL PRECIPATATING REAGENT SET Livonia Diagnostics, Inc. LBR Class I 1984-11-02
K843540 ABBOTT HTSH EIA DIAGNOSTIC KIT Abbott Laboratories JLW Class II 1984-11-02
K842772 PHARMACIA B2-MICRO RIA Pharmacia, Inc. JGZ Class II 1984-11-01
K843997 AO-10 AUTOMATED OSMOMETER bioMerieux, Inc. JJM Class I 1984-10-31

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