meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
58
Latest Decision
1984-10-31

Clearances · page 96 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K843774 RAICHEM X-HBDH REAGENT Reagents Applications, Inc. JMK Class I 1984-10-31
K843668 PHOTOMETER 90IYS Institute Virion , Ltd. JJQ Class I 1984-10-30
K843938 LINEAR ENZYMATIC URIC ACID SYSTEM Simmler, Inc. KNK Class I 1984-10-30
K843893 MAGNESIUM REAGENT SET Livonia Diagnostics, Inc. JGJ Class I 1984-10-30
K843870 PARATHYROID HORMONE MID-MOLECULE RIA-KIT Diagnostic Products Corp. CEW Class II 1984-10-30
K844075 URIC ACID REAGENT SET Livonia Diagnostics, Inc. LFQ Class I 1984-10-30
K843871 PARATHYROID HORMONE C-TERMINAL RIA KIT Diagnostic Products Corp. CEW Class II 1984-10-30
K844024 CREATININE REAGENT SET Livonia Diagnostics, Inc. CGX Class II 1984-10-30
K843916 TDX REA CREATININE Abbott Laboratories CGX Class II 1984-10-30
K844011 FOCUS URIC ACID Abbott Laboratories KNK Class I 1984-10-30
K843930 IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I Euro-Diagnostics BV CGJ Class I 1984-10-30
K843895 TOTAL CALCIUM REAGENT SET Livonia Diagnostics, Inc. CIC Class II 1984-10-30
K843795 BETA QUIK V Pacific Biotech, Inc. JHI Class II 1984-10-30
K841088 SOMATOMEDIN-C RADIOIMMUNOASSAY KIT Nichols Institute Diagnostics CFL Class I 1984-10-22
K843947 DOUMENT TM LINEARITY TEST STANDARDS Casco Standards JIX Class II 1984-10-17
K843082 ANALOX LM3 MICRO-STAT ANALYSER Analox Instruments , Ltd. JJE Class I 1984-10-17
K843239 DACOS PLUS LYTES OPTION Coulter Electronics, Inc. CEM Class II 1984-10-17
K843395 ENCORE TSH REAGENT Hybritech, Inc. JLW Class II 1984-10-11
K842966 RENIN RADIOIMMUNOASSAY TEST KIT Serono Diagnostics, Inc. CIB Class II 1984-10-11
K843831 ALBUMIN REAGENT SET Livonia Diagnostics, Inc. CIX Class II 1984-10-11
K843059 ATAC 2000 Turpen Laboratory Systems, Inc. JJE Class I 1984-10-11
K843529 ASTRA SYSTEMS AMYLASE REAGENT KIT Beckman Instruments, Inc. CJA Class II 1984-10-11
K843536 TRIGLYCERIDE ASSAY KIT GPO-CP Diagnostic Chemicals, Ltd. (Usa) CDT Class I 1984-10-11
K841648 DIAGEM DIGITAL BLOOD GLUCOSE MONITOR Forward Medical Supplies JJQ Class I 1984-10-11
K843685 C-TERMINAL/MID-MOLECULE PARATHYROID - Nichols Institute Diagnostics CEW Class II 1984-10-11
K842873 STANDARDS & ACCESSORIES FOR NOVA INSTRU Diagnostic Chemicals, Ltd. (Usa) JGS Class II 1984-10-05
K843565 KOVA TROL I,II, III HUMAN URINE-DRIED Icl Scientific JJW Class I 1984-10-05
K843610 PERSPECTIVE CHEMICAL ANALYZER American Monitor Corp. JJE Class I 1984-10-05
K842909 LIQUID CHROMATOGRAPHY COLUMNS;ION EXCH Supelco, Inc. DPM Class I 1984-10-05
K843434 ISO-DATA CENTRIFUGES 1-A, 101, 2D, ETC. Iso-Data, Inc. JQC Class I 1984-10-05
K843111 ROCHE REAGENT FOR ALT Roche Diagnostic Systems, Inc. CKA Class I 1984-10-05
K843283 BOEHRINGER MANNHEIM DIAGNOSTICS ADAM Boehringer Mannheim Corp. JJE Class I 1984-10-05
K843740 SCLAVO CHLORIDE TEST Sclavo, Inc. CHJ Class II 1984-10-05
K843407 ENCORE HCG REAGENT Hybritech, Inc. JHI Class II 1984-10-04
K843545 TSH QUIK RIA KIT Pacific Biotech, Inc. JLW Class II 1984-10-02
K843701 TOTAL PROTEIN REAGENT SET Livonia Diagnostics, Inc. CEK Class II 1984-10-01
K842654 EPSILON HCG TEST KIT MONOCLONAL Beckman Instruments, Inc. JHI Class II 1984-10-01
K843510 PDA CHOLESTEROL Abbott Laboratories CHH Class I 1984-09-28
K843621 FIAX 420 DILUTOR Intl. Diagnostic Technology JQW Class I 1984-09-28
K842018 ISO-SEP SYSTEM Berwick Medical Products, Inc. CEX Class II 1984-09-28
K843003 GLUCOSE AUTO& STAT GA-1120 Kyoto Diagnostics, Inc. CGA Class II 1984-09-28
K843222 ENZYMATIC CHOLESTEROL KIT Livonia Diagnostics, Inc. CHH Class I 1984-09-28
K843528 GLUCOSE OXIDASE ENZYMATIC REAGENT SET Livonia Diagnostics, Inc. CGA Class II 1984-09-28
K843377 CREATININE ASSAY KIT Diagnostic Chemicals, Ltd. (Usa) CGX Class II 1984-09-28
K842755 TITAN GEL ISO DOT CPK PROCEDURE Helena Laboratories CGS Class II 1984-09-28
K843379 VMA ASSAY KIT Diagnostic Chemicals, Ltd. (Usa) CDF Class I 1984-09-28
K843384 LEECO CORTISOL-QUANT Leeco Diagnostics, Inc. CGR Class II 1984-09-28
K843569 PRECISET AMMONIA Boehringer Mannheim Corp. JJX Class I 1984-09-28
K834474 H.P.T. HOME PREG. TEST KIT & A.P.T. Biomedical Research & Development Laboratories, Inc. LCX Class II 1984-09-28
K843645 SYSTEMATE A AMYLASE HEM 67204 Em Diagnostic Systems, Inc. CIJ Class II 1984-09-28
K843541 PDA GLUCOSE Abbott Laboratories CFR Class II 1984-09-28
K843611 QUALIFY I & II AMER. MONITOR 2009 & 2010 American Monitor Corp. JJY Class I 1984-09-28
K843635 MATCHED COMPONENT SET FOR RADIOIMMUNO- Cambridge Medical Technology JKC Class I 1984-09-28
K843452 STANDARD & SOLUTIONS FOR NOVA 4 ANALYZ Fisher Scientific Co., LLC JGS Class II 1984-09-27
K842960 ANDROSTENEDIONE BY RIA Radioassay Systems Laboratories, Inc. CIZ Class I 1984-09-27
K843365 ISO-DATA IMMUNOASSAY NETWORK SYSTEM Iso-Data, Inc. JQP Class I 1984-09-27
K843460 ULTRAVIOLET-VISIBLE SPECTROPHOTOMETER Varian Assoc., Inc. JJQ Class I 1984-09-26
K843552 TRIGLYCERIDES GPO REAGENT Bio-Rad CDT Class I 1984-09-26
K843281 ACCUSCREEN TSH Neometrics, Inc. JLW Class II 1984-09-26
K842544 STANBIO QUICK-TELL MONOCLONAL INDIRECT Stanbio Laboratory JHJ Class II 1984-09-21
K843607 LABOPETTOR Medical Technomics, Ltd. JQW Class I 1984-09-21
K843606 PRECISION DISPENSER Medical Technomics, Ltd. JQW Class I 1984-09-21
K843329 SYSTEMATE D-BILI 67213 Em Diagnostic Systems, Inc. CIG Class II 1984-09-20
K843333 SYSTEMATE GOT 67208 Em Diagnostic Systems, Inc. CIT Class II 1984-09-20
K843334 SYSTEMATE GPT 67209 Em Diagnostic Systems, Inc. CKA Class I 1984-09-20
K843328 SYSTEMATE T-BILI 67212 Em Diagnostic Systems, Inc. CIG Class II 1984-09-20
K843380 ACID PHOSPHATASE ASSAY KIT Diagnostic Chemicals, Ltd. (Usa) CKE Class II 1984-09-20
K843353 RAICHEM CALCIUM REAGENT Reagents Applications, Inc. CIC Class II 1984-09-20
K843183 STRATUS CORTISOL FLUOROMETRIC ENZYME American Dade CGR Class II 1984-09-17
K842499 NMS 1043 ENZYME IMMUNOASSAY KIT Nms Pharmaceuticals, Inc. JHI Class II 1984-09-14
K842786 DYNA-LYTE 2000 Abbott Diagnostics CEM Class II 1984-09-14
K842957 CORITSOL PREMIX RIA KIT Biotecx Laboratories, Inc. CGR Class II 1984-09-14
K843397 CORNING HIGH RESOLUTION PROTEIN ELECTRO Corning Medical & Scientific CEF Class I 1984-09-14
K842947 MICROBIOLOGICAL TRAY READER-MANUAL American Micro Scan JJQ Class I 1984-09-14
K843174 DRI-STAT ENZYMATIC BILIRUBIN TEST KIT Beckman Instruments, Inc. JFM Class II 1984-09-14
K843255 TECHNICON RA-1000 SYS IRON FOR SERUM Technicon Instruments Corp. JIY Class I 1984-09-14
K843177 INORGANIC PHOSPHORUS TEST Sclavo, Inc. CEO Class I 1984-09-14
K843238 ANSWER ONE-DAY Armkel, LLC LCX Class II 1984-09-14
K843326 SYSTEMATE BUN HEM NO. 67221 Em Diagnostic Systems, Inc. CDQ Class II 1984-09-14
K842770 MACBETH COLOR EIAD 100/100PC Macbeth JJQ Class I 1984-09-14
K843330 SYSTEMATE PHOSPHORUS 67217 Em Diagnostic Systems, Inc. CEO Class I 1984-09-14
K843327 SYSTEMATE CHOLESTEROL 67222 Em Diagnostic Systems, Inc. CHH Class I 1984-09-14
K843332 ALKALINE PHOSPHATASE REAGENT SET Sterling Biochemical, Inc. CJE Class II 1984-09-14
K842478 PROLACTIN IRMA Euro-Diagnostics BV CFT Class I 1984-09-14
K843268 SYSTEMATE 2GT - 67207 Em Diagnostic Systems, Inc. JQB Class I 1984-09-13
K842443 AXIOM STABLE II TRIGLYCERIDES TEST Axiom, Inc. CDT Class I 1984-09-13
K843266 ID ZONE NORMAL LD ISOENZYME CONTROL Beckman Instruments, Inc. JJT Class I 1984-09-13
K843270 SYSTEMATE ALKALINE PHOSPHATASE-67203 Em Diagnostic Systems, Inc. CJE Class II 1984-09-13
K843265 ID ZINE LD ISOENZYME CONTROL ABNORM Beckman Instruments, Inc. JJT Class I 1984-09-13
K843296 ELVI 675 DIGITRON Logos Scientific, Inc. JJQ Class I 1984-09-13
K843325 SYSTEMATE URIC ACID, HEM 67220 Em Diagnostic Systems, Inc. KNK Class I 1984-09-13
K843269 SYSTEMATE LDH, 67210 Em Diagnostic Systems, Inc. CFJ Class II 1984-09-13
K843112 ROCHE STANDARDS FOR URIC ACID Roche Diagnostic Systems, Inc. JIT Class II 1984-09-13
K842366 OXALATE URINE CONTROLS NORMAL & ELEVAT Sigma Chemical Co. JJW Class I 1984-09-12
K842593 SUCROSEP THYROID STIMULATING HORMONE Boots-Celltech Diagnostics, Inc. JLW Class II 1984-09-12
K842313 ELVI 146 SEROSCAN Logos Scientific, Inc. JQT Class I 1984-09-10
K843179 CREATININE TEST Sclavo, Inc. CGX Class II 1984-09-07
K843178 TOTAL BILIRUBIN TEST Sclavo, Inc. CIG Class II 1984-09-07
K843104 ALBUMIN ASSAY KIT Diagnostic Chemicals, Ltd. (Usa) CIX Class II 1984-09-07
K843007 CARDI-CK EIA TEST KIT CK-MB ISOENZYME Intl. Immunoassay Laboratories, Inc. JHS Class II 1984-09-07

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