meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
63
Latest Decision
1983-06-02

Clearances · page 104 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K831361 BETA-PREG Catheter Technology Corp. JHJ Class II 1983-06-02
K831221 RIAGEN B-HCG RIA KIT Biogenex Laboratories JHI Class II 1983-06-02
K831155 B-CLONE HCG ASSAY Monoclonal Antibodies, Inc. JHJ Class II 1983-06-02
K831342 COAT-A-COUNT NO-EXTRACTION TESTOSTERONE Diagnostic Products Corp. CDZ Class I 1983-06-02
K831180 PREGNA-CERT, SLIDE PREGNANCY TEST Diagnostic Specialties JHJ Class II 1983-05-27
K831178 COAT-A-COUNT NO-EXTRACTION ALDOSTERONE Diagnostic Products Corp. CJM Class II 1983-05-27
K831141 EMIT SRD MANUAL CORTISOL ASSAY Syva Co. CGR Class II 1983-05-27
K831202 SERUM UIBC-PTF-600 METHOD American Monitor Corp. JMO Class I 1983-05-25
K831015 DIAGNOSTICS PH ELECTRODE CLEANING SOLUT Fisher Scientific Co., LLC CHL Class II 1983-05-25
K831201 SERUM IRON-PTF-600 American Monitor Corp. JIY Class I 1983-05-25
K830980 AMERLEX FREE T-3 RIA KIT Amersham Corp. CDP Class II 1983-05-25
K831051 HOME PREGNANCY TEST KIT HPK #1 Quidel Corp. LCX Class II 1983-05-18
K831107 COAT-A-COUNT NEONATAL T4 KIT RIA KIT Diagnostic Products Corp. CDX Class II 1983-05-18
K831108 HOME PREGNANCY TEST KIT Quidel Corp. LCX Class II 1983-05-18
K831242 LITHIUM HEPARINIZED BLOOD COLLECT-TUBE American Dade JKA Class II 1983-05-16
K831081 EZEE FILTER/SEPARATOR The Kendall Company Div. of Tyco Healthcare Group JKA Class II 1983-05-16
K831105 CORDIA PAP Cordis Corp. JFH Class II 1983-05-16
K831027 EXTRELUT QE EXTRACTION COLUMNS Emd Chemicals, Inc. KEA Class I 1983-05-16
K830978 HELENA BIOSTRIP A Helena Laboratories JMA Class I 1983-05-13
K830563 CORTISOL RADIOIMMUNOASSAY KIT-CORTCTK Sorin Biomedica, Fiat, USA, Inc. CGR Class II 1983-05-13
K831020 FLUSH SOLUTION CONCENTRATE Fisher Scientific Co., LLC CHL Class II 1983-05-09
K830664 HUMAN INTRACT PARATHYROID HORMONE BY Immuno Nuclear Corp. CEW Class II 1983-05-09
K831064 PHASE II T3 RADIOIMMUNOASSAY KIT Medical & Scientific Designs, Inc. CDP Class II 1983-05-09
K831017 BUFFER PACK FOR ABL-1 & ABL-2 Fisher Scientific Co., LLC CHL Class II 1983-05-09
K831030 COBAS STANDARDS FOR GLUCOSE & BUN Roche Diagnostic Systems, Inc. JIX Class II 1983-05-09
K831016 BATH CLEAR Fisher Scientific Co., LLC CHL Class II 1983-05-05
K830979 HELENA BIOSTRIP PH Helena Laboratories CEN Class I 1983-05-05
K831125 BTC URINE LCG ASSAY Btc Diagnostics, Inc. JHJ Class II 1983-05-05
K831010 DIAGNOSTICS PO2 ELECTRODE CLEANER Fisher Scientific Co., LLC CHL Class II 1983-05-05
K830958 FLOW-PAC SGOT REAGENT Amresco, Inc. CIT Class II 1983-05-04
K830975 PLAN A LIFE New Directions Co. JIN Class I 1983-05-04
K830959 FLOW-PAC SGPT REAGENT Amresco, Inc. CKA Class I 1983-05-04
K830976 HELENA BIOSTRIP K Helena Laboratories JIN Class I 1983-05-04
K830977 HELENA BIOSTRIP P Helena Laboratories JIR Class I 1983-04-28
K830928 VENTREX ENZYME TSH KIT Ventrex Laboratories, Inc. JLW Class II 1983-04-28
K830589 ELECTROLYTE STANDARD - CORNING NALK ISE Shaban Mfg. Co. JGS Class II 1983-04-27
K830918 I.E.C COLUMN Berwick Medical Products, Inc. KEA Class I 1983-04-27
K830588 POTASSIUM ANALYZER-SODIUM/ELECTROLYTE Shaban Mfg. Co. JGS Class II 1983-04-27
K830893 ACTH RIA SYSTEM-DSI 2300 Diagnostic Systems Laboratories, Inc. CKG Class II 1983-04-27
K830900 UPTAKE T3 RADIOIMMUNOASSAY KIT Medical & Scientific Designs, Inc. KHQ Class II 1983-04-18
K830761 WAKO FREE CHOLESTEROL C TEST Wako Chemicals USA, Inc. CHH Class I 1983-04-18
K830880 IMMO PHASE DIRECT PROGESTERONE RADIO- Corning Medical & Scientific JLS Class I 1983-04-18
K830934 QUANTIMETRIX BROMERESOL PURPLE ALBUMIN Quantimetrix Corp. CJW Class II 1983-04-18
K830493 PROTOPORPHYRIN ZN CONTROL Kaulson Laboratories, Inc. JJX Class I 1983-04-18
K823860 NUCLIPASE (I125) PANCREATIC LIPASE Nuclear Diagnostics, Inc. CET Class I 1983-04-18
K830872 TITAN GEL LDH ISO-ENZYME CONTROL Helena Laboratories CFE Class II 1983-04-12
K830799 INDUCTIVELY-COUPLED PLASMA SPECTROMETER The Perkin-Elmer Corp. JXR Class I 1983-04-12
K830912 TDX T-UPTAKE Abbott Laboratories KHQ Class II 1983-04-12
K830762 OLYMPUS HIGH SPEED ANALYZER Olympus Corp. JJE Class I 1983-04-12
K830816 DSL 1900 Diagnostic Systems CGI Class I 1983-04-12
K830834 NEGATIVE URINE CONTROL Helena Laboratories JJW Class I 1983-04-12
K830569 CYNOX I HEMOGLOBINOMETER Buffalo Medical Specialties Mfg., Inc. JJQ Class I 1983-04-08
K830808 LEECO T3-RIA DIAGNOSTIC KIT Leeco Diagnostics, Inc. CDP Class II 1983-04-08
K830679 URIC ACID COLORIMETRIC DETERMINATION Dow Instruments & Reagents, Inc. KNK Class I 1983-04-06
K830751 KEMTEK 102 Kemble Instruments, Inc. JJJ Class I 1983-04-06
K830683 TDX THYROXINE Abbott Laboratories KLI Class II 1983-04-06
K830714 TOTAL BILIRUBIN REAGENT Hi Chem, Inc. CIG Class II 1983-04-06
K830700 MMH PTH RIA KIT Diagnostic Systems CEW Class II 1983-04-06
K830212 ELISA PLUS SYSTEM William-Palmer Industries, Inc. JJE Class I 1983-04-05
K830624 FLUOROMETER, GENERAL USE Abbott Diagnostics KHO Class I 1983-04-05
K830672 CREATINE KINASE REAGENT SET Sterling Biochemical, Inc. JHY Class II 1983-04-05
K823421 PHADEBAS HUMYLASE CONTROL(H) Pharmacia, Inc. JJX Class I 1983-04-05
K830641 ENCORE CHEMISTRY ANALYZER Baker Instructions Corp. JJG Class I 1983-04-05
K830241 ULTRA CHEM BUN-UV #65080-65081 Emd Chemicals, Inc. CDQ Class II 1983-04-05
K830692 DUPONT PREP OD EXTRACTION CARTRIDE E.I. Dupont DE Nemours & Co., Inc. DJY Class I 1983-04-05
K830642 PHASE THYROXINE RADIOIMMUNOASSAY KIT Medical & Scientific Designs, Inc. CDX Class II 1983-04-05
K830412 RADIOIMMUNOASSAY TEST SYSTEM PRL Monobind CFT Class I 1983-04-05
K830693 DUPONT PREP TYPE AS EXTRACTION CARTRIDE E.I. Dupont DE Nemours & Co., Inc. DJY Class I 1983-04-05
K830526 B-GCG SYSTEM BY RIA Pcl-Ria, Inc. JHI Class II 1983-04-05
K830213 NOVA 7 TOTAL CALCIUM/IONIZED CALCIUM Nova Biomedical Corp. JFP Class II 1983-04-05
K830616 ACTIVATED URIC ACID American Monitor Corp. CHD Class I 1983-04-05
K830769 FEKAL CON-TRATE SYSTEM Trend Scientific, Inc. KLI Class II 1983-04-05
K830512 LEECO TESTOSTERONE DIAGNOSTIC KIT Leeco Diagnostics, Inc. CDZ Class I 1983-04-05
K830239 ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDA Emd Chemicals, Inc. CHH Class I 1983-04-05
K830564 FEB TEST Wako Chemicals USA, Inc. CFM Class I 1983-03-29
K830695 BETA-COTE B-HCG PREGNANCY SCREENING SYS Bd Becton Dickinson Vacutainer Systems Preanalytic JHI Class II 1983-03-29
K830319 AUTO PREP Pm America, Inc. JQW Class I 1983-03-29
K830296 CORNING 102 PRINTER Corning Medical & Scientific JQP Class I 1983-03-25
K830555 AMRESCO UREA NITROGEN REAGENT SET Amresco, Inc. CDQ Class II 1983-03-24
K830537 FLOW-PAC CREATININE REAGENT SET Amresco, Inc. CGX Class II 1983-03-24
K830469 BILIRUBIN STANDARD-LYOPHILIZED Dow Instruments & Reagents, Inc. JIT Class II 1983-03-24
K830556 CREATININE Pointe Scientific, Inc., CGX Class II 1983-03-24
K830502 NOVA 8 IONIZED CALCIUM/PH ANALYZER Nova Biomedical Corp. JFP Class II 1983-03-24
K830538 FLOW-PAC TOTAL PROTEIN REAGENT SET Amresco, Inc. CEK Class II 1983-03-24
K830447 KINETIC CREATININE American Monitor Corp. CGX Class II 1983-03-24
K830535 FLOW-PAC ALKALINE PHOSPHATE REAGENT SET Amresco, Inc. CJF Class II 1983-03-24
K830536 FLOW-PAC ALBUMIN REAGENT Amresco, Inc. CIX Class II 1983-03-24
K830207 RAICHEM HDL-CHOLESTEROL REAGENT Reagents Applications, Inc. LBR Class I 1983-03-21
K830365 KINETI COUNT 48 IMMUNOASSAY SYSTEM Medical & Scientific Designs, Inc. JJJ Class I 1983-03-10
K830341 SALT BRIDGE SOLUTION & URINE DILUENT Shaban Mfg. Co. JIX Class II 1983-03-10
K830157 DIGIFLEX AUTOMATIC PIPETTE Micromedic Systems JQW Class I 1983-03-10
K822721 NO-BOIL SOLID PHASE SIMUL TRAC B12 Bd Becton Dickinson Vacutainer Systems Preanalytic CDD Class II 1983-03-10
K830318 PARAMAX ANALYTICAL SYS American Dade JJE Class I 1983-03-07
K823512 MR 600 MICROPLATE READER Laboratory and Medical Products Group JJQ Class I 1983-03-01
K830309 ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDASE Emd Chemicals, Inc. CHH Class I 1983-02-28
K830181 REFEREE BLOOD GAS ANALYZER CONTROLS Analytical Products, Inc. JJS Class I 1983-02-28
K830283 LITHIUM DILUENT Shaban Mfg. Co. JIS Class II 1983-02-28
K830308 ULTRA ZYME PLUS GAMMA GT #65055 & 56 Emd Chemicals, Inc. JQB Class I 1983-02-28
K823590 MANUALISA MICROTITRATION PLATE READER Ortho Diagnostic Systems, Inc. JJQ Class I 1983-02-28
K830288 TRIGLYCERIDE DIAGNOSTIC KIT Sclavo, Inc. CDT Class I 1983-02-25

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