meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
61
Latest Decision
1985-10-01

Clearances · page 92 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K852391 EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE Helena Laboratories CFH Class II 1985-10-01
K852538 LKB 4057 ULTROSPEC II E Lkb Instruments, Inc. JJQ Class I 1985-09-30
K853825 URIC ACID(URICASE) FOR CONTINUOUS FLOW INSTRUMENTS Catachem, Inc. KNK Class I 1985-09-30
K853453 BIO AUTOMED SYS CHEMISTRY ANALYZER AUTO-LOADER Bio Automed Systems, Inc. JJQ Class I 1985-09-30
K853826 GLUCOSE HEXOKINASE FOR CONTINUOUS FLOW INSTRUMENTS Catachem, Inc. CFR Class II 1985-09-30
K853868 ALBUMIN SR LIQUID STABLE REAGENT SET Medical Analysis Systems, Inc. CIX Class II 1985-09-30
K853887 LIQUI-SERA CHEM. MULTIPLE CALIBRATORS Biodiagnostic Intl JIT Class II 1985-09-30
K852411 MR 650 MICROPLATE READER(CAT. NO. 011-973-0500) Dynatech Laboratories, Inc. JJQ Class I 1985-09-30
K853699 EASY ANALYZER & EASY-TEST REAGENT Diagnostic Systems JJE Class I 1985-09-25
K853539 ABBOTT TESTPACK HCG(URINE) DIAGNOSTIC KIT Abbott Laboratories JHI Class II 1985-09-25
K853734 APOLLO DENSITOMETER Astral Medical Systems JQT Class I 1985-09-25
K853628 SIMULTRAC FREE T4(57CO)/TSH[125I] RADIOIMMUNOASSAY Bd Becton Dickinson Vacutainer Systems Preanalytic CEC Class II 1985-09-18
K853677 TDX REA BUN Abbott Laboratories CDQ Class II 1985-09-16
K853127 MICROMEDIC COMBOSTAT B B12/FOLATE(BOIL) Micromedic Systems CDD Class II 1985-09-16
K853533 ABSORBANCE TEST SOLUTION Diagnostic Systems JIT Class II 1985-09-16
K853656 QCA ENZYMATIC GLUCOSE Bd Becton Dickinson Vacutainer Systems Preanalytic CGA Class II 1985-09-16
K853553 DIASCAN CONTROL Home Diagnostics, Inc. JJX Class I 1985-09-16
K852133 REFLOTRON SYSTEM Boehringer Mannheim Corp. JJE Class I 1985-09-16
K853592 MAGNESIUM Pointe Scientific, Inc., JGJ Class I 1985-09-16
K851450 FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM Flow Cytometry Standards Corp. JIW Class II 1985-09-16
K852845 PROSTATIC ACID PHOSPHATASE RADIOIMMUNOASSAY Diagnostic Products Corp. JFH Class II 1985-09-04
K853247 ACU-SLIDE-TEST Cal-Tech Diagnostics, Inc. JHJ Class II 1985-09-04
K853006 HUMAN CHORIONIC GONAD TEST SYS FOR EARLY PREGNANCY Modern Diagnostics, Inc. JHI Class II 1985-09-04
K853464 GLUCOSE SR LIQUID STABLE REAGENT SET Medical Analysis Systems, Inc. CFR Class II 1985-09-04
K853531 ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZER American Dade CEM Class II 1985-09-04
K852611 TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE Miles Laboratories, Inc. CDM Class I 1985-09-03
K853356 SERA-210 ELECTROLYTE ANALYZER Horiba Instruments, Inc. CEM Class II 1985-09-03
K850368 SIGMS B-HYDROXYBUTARATE PROCEDURE NO. 310-UV Sigma Chemical Co. JIN Class I 1985-08-30
K852867 HI-CHEM DIAGNOSTICS ENZYME RINSE CONCENTRATE Hi Chem, Inc. CKA Class I 1985-08-29
K844948 SYVA SOLID PHASE COLUMNS Syva Co. KEA Class I 1985-08-29
K851703 GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT Miles Laboratories, Inc. CGA Class II 1985-08-23
K853152 MONOJECT SAMPLE CAPILLARY PLASMA SEP W/LITH HEPAR Sherwood Medical Co. JKA Class II 1985-08-23
K853404 QCA POTASSIUM TEST KIT Bd Becton Dickinson Vacutainer Systems Preanalytic CEJ Class II 1985-08-23
K853373 DELTA TROL I & II Electro-Nucleonics Laboratories, Inc. JJT Class I 1985-08-23
K853174 APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN Photec Diagnostics, Inc. MSJ Class I 1985-08-22
K852481 UNI PAK 500 ANALYZER + CHEMISTRY REAGENT ITEM Em Diagnostic Systems, Inc. JJQ Class I 1985-08-21
K852441 IN VITRO TESTS FOR PHOSPHATASE & BLOOD NITROGEN Clinical Data, Inc. CJE Class II 1985-08-21
K852169 CHLORIDE REAGENT Pointe Scientific, Inc., CHJ Class II 1985-08-21
K851377 DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA Diagnon Corp. CDD Class II 1985-08-21
K852327 BETA QUIK STAT Pacific Biotech, Inc. JHI Class II 1985-08-20
K853357 URIC ACID REAGENT Sigma Diagnostics, Inc. KNK Class I 1985-08-19
K853208 125I ESTRADIOL DIRECT RADIOIMMUNOASSAY Travenol Laboratories, S.A. CHP Class I 1985-08-19
K852261 YSI MODEL 2372 TOTAL BLOOD LACTATE KIT Yellow Springs Instrument Co., Inc. KHP Class I 1985-08-15
K853244 TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/ROU ANALYZE Simmler, Inc. CEK Class II 1985-08-12
K850950 VISION POTASSIUM Abbott Laboratories CEM Class II 1985-08-12
K853041 TRIGLYCERIDES LCK 124 German American Chamber of Commerce, Inc. CDF Class I 1985-08-12
K852537 T-3 RIASSAY Ria Diagnostics CDP Class II 1985-08-12
K852948 AMRESCO SUBST CONCEN, PRO #2432,BUF,NAD,2455,TRI Amresco, Inc. CFJ Class II 1985-08-07
K851689 GENESYS GAMMA COUNTER Laboratory Technologies, Inc. JJJ Class I 1985-08-07
K851618 DIASCAN BLOOD GLUCOSE SELF-MONITOR TEST STRIPS Home Diagnostics, Inc. CGA Class II 1985-08-06
K853003 HI CHEM DIAGNOSTICS CLEANING NEUTRALIZER SOL#88193 Hi Chem, Inc. JJE Class I 1985-08-06
K852927 TDX CORTISOL Abbott Laboratories JFT Class II 1985-08-05
K852306 REPLACEMENT REAGENTS FOR SMAC II SYSTEMS Methodist Hospital of Memphis JJC Class I 1985-08-02
K853102 UREASE & GLUTAMATE DEHYDROGENASE, UREA NITROGEN Diagnostic Chemicals, Ltd. (Usa) CDQ Class II 1985-08-02
K853026 BIOVATION MAX DATA MANAGEMENT SYSTEM Biovation, Inc. JQP Class I 1985-08-02
K853050 CALCIUM REAGENT FOR ASTRA 8 AUTOM STAT/ROUT/ANALYZ Simmler, Inc. CIC Class II 1985-08-02
K852847 SOPHEIA DHEA-SO4 EIA KIT Diagnostic Products Corp. JKC Class I 1985-08-02
K853049 ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZE Simmler, Inc. CIX Class II 1985-08-02
K852753 DC LIQUITROL LEVEL 1 & 2 Diagnostic Chemicals, Ltd. (Usa) JJY Class I 1985-08-02
K852434 1208 BETACORD AND 1208 BETCORD M Lkb Instruments, Inc. JJJ Class I 1985-08-02
K852939 CORTISOL SYSTEM BY EIA American Bioclinical, Inc. CGR Class II 1985-08-02
K851456 ACCU-CHEK II Boehringer Mannheim Corp. CGA Class II 1985-08-01
K851445 COLOR OVULATION TEST Nms Pharmaceuticals, Inc. CEP Class I 1985-07-29
K852146 QUIDEL QUEST OVULATION TEST Quidel Corp. CEP Class I 1985-07-29
K852863 CHOLESTEROL METHOD Catachem, Inc. CHH Class I 1985-07-23
K852752 AMRESCO FLOW PAC ALKALINE PHOSPHATASE BUFFER CONCE American Research Products Co. CJE Class II 1985-07-23
K851641 THROMBOSIL SILICA ACTIVATED PTT REAGENT THROMBOXIL Ortho Diagnostic Systems, Inc. MSJ Class I 1985-07-23
K852164 CEDIA TOTAL T4 ASSAY Microgenics Corp. KLI Class II 1985-07-22
K852675 AMERLEX-M B-HUMAN CHORIONIC GONADTROPIN RADIOI KIT Amersham Corp. JHI Class II 1985-07-22
K852295 UROL-GUANT Dimension Diagnostics JJW Class I 1985-07-22
K852783 SGOT/ALT REAGENT Advanced Biomedical Methods, Inc. CIT Class II 1985-07-22
K852676 IL SYSTEM 1304 & 1306, PH/BLOOD GAS ANALYZERS Allied Instrumentation Laboratory CHL Class II 1985-07-22
K852844 AMRESCO FLOW PAC TOTAL PROTEIN BIURET & BLANK CONC American Research Products Co. CEK Class II 1985-07-22
K852556 TDX REA TRIGLYCERIDES Abbott Laboratories JGW Class I 1985-07-22
K852784 ALKALINE PHOSPHATASE Advanced Biomedical Methods, Inc. CJE Class II 1985-07-22
K852260 QUICK-CHEM CALIBRATION SET Seragen Diagnostics, Inc. JIW Class II 1985-07-22
K841407 ISOGEL AGAROSE Fmc Corp. JJN Class I 1985-07-16
K852418 QCM-SP1(NORMAL CONCENTTRATION) & SP2(ABNORMAL) Amf Biological and Diagnostics Co. JJY Class I 1985-07-15
K852657 AMRESCO CALCIUM REAGENT SET American Research Products Co. CIC Class II 1985-07-15
K851820 SPINAL FLUID CONTROL Irvine Scientific JJY Class I 1985-07-15
K852461 CHEMTRAK LIQUID MULTI-ANALYTE CALIBRATOR, MUL-SET Medical Analysis Systems, Inc. JIT Class II 1985-07-12
K852483 SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205 Em Diagnostic Systems, Inc. CGS Class II 1985-07-12
K852437 VISUAL SERUM/URINE HCG COMBO KIT American Bioclinical, Inc. JHI Class II 1985-07-12
K851393 DUPONT PREP FOUR-SOLVENT RETROFIT KIT E.I. Dupont DE Nemours & Co., Inc. JJH Class I 1985-07-12
K852636 X-AMYLASE ASSAY KIT Diagnostic Chemicals, Ltd. (Usa) CIJ Class II 1985-07-12
K852565 TECHNICON CHEMI Technicon Instruments Corp. CGX Class II 1985-07-12
K852594 DC-LIP, CATALOGUE NUMBER SE-020 Diagnostic Chemicals, Ltd. (Usa) JJY Class I 1985-07-12
K852058 CHLORIDE ASSAY KIT Diagnostic Chemicals, Ltd. (Usa) CHJ Class II 1985-07-12
K852438 NML TSH IRMA Nuclear Medical Laboratories, Inc. JLW Class II 1985-07-12
K852473 ION-SPECIFIC ELECTRODE OPTION FOR COBAS FARA Roche Diagnostic Systems, Inc. JGS Class II 1985-07-12
K852595 DC-3 FLUIDS PACK, DC-5 FLUIDS PACK Diagnostic Chemicals, Ltd. (Usa) JGS Class II 1985-07-12
K852583 DATA CHEM IRON PROCEDURE Data Medical Associates, Inc. CFM Class I 1985-07-12
K852385 HYBRITECH IMMUNOCHEMISTRY ANALYZER Hybritech, Inc. JJF Class I 1985-07-12
K851389 APO B RIA KIT Iso-Tex Diagnostics MSJ Class I 1985-07-10
K851332 BLHI LUTEINIZING HORMONE Euro-Diagnostics BV CEP Class I 1985-07-09
K852183 BETA HCG EXTENDED RANGE ACCESSORY KIT Abbott Laboratories JHI Class II 1985-07-09
K852224 LEE-BEAD TSH(EIA) Lecco Diagnostics, Inc. JLW Class II 1985-07-09
K852299 TERUMO SENSIBEAD EIA HGH KIT Terumo Medical Corp. CFL Class I 1985-07-09
K852285 DADE BLOOD GAS AMPUL INJECTOR American Dade JQW Class I 1985-07-09
K851100 CHEM PRO 1000 CHEMISTRY ANALYSIS Sen Tech Medical Corp. CEM Class II 1985-07-09

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