meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
57
Latest Decision
1986-07-01

Clearances · page 88 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K861670 TRIGLYCERIDE (TRINDER) PROCEDURE Data Medical Associates, Inc. CDT Class I 1986-07-01
K862179 SOMAS LIQUID URINE CONTROL Somas Medical Industries, Inc. JJY Class I 1986-07-01
K861696 ELECTROLYTE ANALYZER ACCESSORY FOR HITACHI 704 Boehringer Mannheim Corp. JGS Class II 1986-07-01
K861664 AMYLASE PROCEDURE Data Medical Associates, Inc. CIJ Class II 1986-07-01
K861661 INORGANIC PHOSPHORUS PROCEDURE Data Medical Associates, Inc. CEO Class I 1986-07-01
K861666 BLOOD UREA NITROGEN (BUN) PROCEDURE Data Medical Associates, Inc. CDQ Class II 1986-07-01
K862256 ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET Sterling Diagnostics, Inc. CJE Class II 1986-07-01
K861314 CHOLESTEROL CALIBRATORS Sigma Diagnostics, Inc. JIT Class II 1986-07-01
K862109 ENZYMUN TEST TBG Boehringer Mannheim Corp. CEE Class II 1986-06-30
K861580 PROGROUP (TM) AUTOMATED LIQUID HANDLING SYSTEM Cetus Corp. JQW Class I 1986-06-27
K861361 ESTRADIOL MAIA RIA KIT MAGNETIC SEPARATION PHASE Serono Diagnostics, Inc. CHP Class I 1986-06-27
K861775 TWIN BUN/GLUCOSE Boehringer Mannheim Corp. CDW Class II 1986-06-27
K861635 TRIGLYCERIDES GPO-TRINDER Catachem, Inc. CDT Class I 1986-06-27
K860664 CRESOLPHTHALEIN COMPLEXONE, CALCIUM Amresco, Inc. CIC Class II 1986-06-27
K862249 TSH IRMA KIT Pacific Biotech, Inc. JLW Class II 1986-06-27
K861793 TWIN TRIGLYCERIDES GPO/CHOLESTEROL Boehringer Mannheim Corp. CDT Class I 1986-06-27
K861926 WORTHINGTON HDL PRECIPITATING REAGENT SET Cooper Biomedical, Inc. LBR Class I 1986-06-27
K861387 KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CK-MB) Eastman Kodak Company JHS Class II 1986-06-27
K861271 SUCROSEP HUMAN PROLACTIN (HPR) IRMA Boots-Celltech Diagnostics, Inc. CFT Class I 1986-06-27
K861998 TOTAL BILIRUBIN TEST KIT Ciba Corning Diagnostics Corp. CIG Class II 1986-06-27
K861671 DIRECT BILIRUBIN PROCEDURE Data Medical Associates, Inc. CIG Class II 1986-06-25
K861274 DOUBLE ANTIBODY CALCITONIN RIA KIT Diagnostic Products Corp. JKR Class II 1986-06-25
K861366 ALT-30, 60 AND 100 Dimension Diagnostics CKA Class I 1986-06-25
K862209 ALT (SGPT) REAGENT SET (UV RATE) Sterling Diagnostics, Inc. CKA Class I 1986-06-25
K861770 PHENYTOIN (FPIA) CALIBRATOR KIT Windsor Laboratories, Inc. JIS Class II 1986-06-25
K861768 THEOPHYLLINE (FPIA) CALIBRATOR KIT Windsor Laboratories, Inc. JIS Class II 1986-06-25
K861891 TOBRAMYCIN (FPIA) CALIBRATOR KIT Windsor Laboratories, Inc. JIS Class II 1986-06-25
K861769 GENTAMICIN (FPIA) CALIBRATOR KIT Windsor Laboratories, Inc. JIS Class II 1986-06-25
K862043 DELFIA (TM) HFSH KIT Lkb Instruments, Inc. CGJ Class I 1986-06-24
K861573 TERUMO SENSIBEAD EIA TSH KIT Terumo Medical Corp. JLW Class II 1986-06-19
K861798 VISION TOTAL PROTEIN Abbott Laboratories CEK Class II 1986-06-17
K862138 VISION ALBUMIN Abbott Laboratories CJW Class II 1986-06-17
K861542 DELFIA (TM) HUMAN PROLACTIN Lkb Instruments, Inc. CFT Class I 1986-06-17
K862207 QUIDEL BETA STICK PREGNANCY TEST (MODIFICATION) Quidel Corp. LCX Class II 1986-06-17
K861901 MULTI-4 CO-OXIMETER CONTROL Allied Instrumentation Laboratory JJY Class I 1986-06-17
K861920 SIMULTRAC NEONATAL T4(57CO)/TSH(125I) RADIOIMMUNO. Bd Becton Dickinson Vacutainer Systems Preanalytic JLW Class II 1986-06-16
K861855 HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET Sterling Diagnostics, Inc. JKF Class I 1986-06-16
K852960 DIRECT University of Wisconsin CGA Class II 1986-06-16
K861946 PTK PLUS. HOME PREGNANCY TEST Healthcheck Corp. LCX Class II 1986-06-16
K861659 CHOLESTEROL PROCEDURE Data Medical Associates, Inc. CHH Class I 1986-06-13
K861660 URIC ACID PROCEDURE Data Medical Associates, Inc. KNK Class I 1986-06-13
K861945 LEE-BEAD PROLACTIN (EIA) Leeco Diagnostics, Inc. CFT Class I 1986-06-13
K861967 AMRESCO FLOW PAC SODIUM POTASSIUM REAGENT SET American Research Products Co. JGS Class II 1986-06-13
K861654 ALBUMIN PROCEDURE Data Medical Associates, Inc. CIX Class II 1986-06-13
K861968 AMRESCO FLOW PAC INORGANIC PHOSPHRUS REAGENT SET American Research Products Co. CEO Class I 1986-06-13
K862027 LDP REAGENT CARTRIDGE (NO. 88216) Hi Chem, Inc. CFJ Class II 1986-06-13
K855239 BIOTEL (TM)/ DIABETES American Diagnostic Corp. JIL Class II 1986-06-13
K861392 SYVA SOLID PHASE COLUMNS SYSTEM II Syva Co. KZR Class I 1986-06-13
K861663 TOTAL PROTEIN PROCEDURE Data Medical Associates, Inc. CEK Class II 1986-06-13
K861506 DOCUMENT ENZYME LINEARITY TEST SETS Casco Standards JJT Class I 1986-06-13
K861735 TIPSEP-TBG ASSAY Nuclear Diagnostics, Inc. CEE Class II 1986-06-13
K861819 KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CREA) Eastman Kodak Company CGX Class II 1986-06-11
K861700 DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM E.I. Dupont DE Nemours & Co., Inc. CHH Class I 1986-06-11
K861919 VENTREX APO B Ventrex Laboratories, Inc. MSJ Class I 1986-06-06
K861665 CREATINE PHROSPHOKINASE (CK) PROCEDURE Data Medical Associates, Inc. CGS Class II 1986-06-05
K861651 TOTAL BILIRUBIN PROCEDURE Data Medical Associates, Inc. CIG Class II 1986-05-29
K861657 CALCIUM PROCEDURE Data Medical Associates, Inc. CIC Class II 1986-05-29
K861652 IRON PROCEDURE Data Medical Associates, Inc. JIY Class I 1986-05-29
K861638 KINETIC ALKALINE PHOSPHATASE REAGENT KIT Bio-Analytics Laboratories, Inc. CJE Class II 1986-05-29
K861097 TRYPSIN RIA KIT Microanalytic Research, Inc. JNO Class I 1986-05-29
K861718 AMYLASE REAGENT CATALOGUE NOS. 85108 AND 85109 Reagents Applications, Inc. JFJ Class II 1986-05-29
K861667 ALKALINE PHOSPHATASE PROCEDURE Data Medical Associates, Inc. CJE Class II 1986-05-29
K861656 AST/GOT PROCEDURE Data Medical Associates, Inc. CIT Class II 1986-05-29
K861750 CK/LD BUFFER (CAT. NO. 5808) Helena Laboratories CFE Class II 1986-05-29
K860906 STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III American Dade JJY Class I 1986-05-29
K861879 CK REAGENT CARTRIDGE (PRODUCT NO. 88213) Hi Chem, Inc. CGS Class II 1986-05-29
K861269 RAICHEM AMYLASE REAGENT Reagents Applications, Inc. JFJ Class II 1986-05-29
K861675 ACID PHOSPHATASE PROCEDURE Data Medical Associates, Inc. CKB Class II 1986-05-29
K861672 GAMMA GLUTAMYL TRANSFERASE PROCEDURE Data Medical Associates, Inc. JPZ Class I 1986-05-29
K861658 ALT/GPT PROCEDURE Data Medical Associates, Inc. CKA Class I 1986-05-29
K861662 LACTATE DEHYDROGENASE (LD) PROCEDURE Data Medical Associates, Inc. CFJ Class II 1986-05-29
K861669 SODIUM, POTASSIUM AND CHLORIDE PROCEDURE Data Medical Associates, Inc. CGZ Class II 1986-05-27
K861668 MAGNESIUM PROCEDURE Data Medical Associates, Inc. JGJ Class I 1986-05-27
K861633 LIQUID CHROMATOGRAPHY COLUMNS Supelco, Inc. DPM Class I 1986-05-23
K861512 EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95 Em Diagnostic Systems, Inc. JJT Class I 1986-05-23
K861262 MMS T3 UPTAKE Micromedic Systems KHQ Class II 1986-05-23
K861567 CONTROL SERA LEVEL VALUES (MG/DL) E.I. Dupont DE Nemours & Co., Inc. JJY Class I 1986-05-23
K861412 DIRECT READOUT MODULE ACCESSORY E.I. Dupont DE Nemours & Co., Inc. JQP Class I 1986-05-23
K861467 ALBUMIN (BCG) REAGENT Sigma Diagnostics, Inc. CIX Class II 1986-05-23
K861603 IRON PROCEDURE Data Medical Associates, Inc. JJY Class I 1986-05-23
K861602 TOTAL IRON BINDING CAPACITY PROCEDURE Data Medical Associates, Inc. CFM Class I 1986-05-23
K860720 BIOTRACK MONITOR (BIOTRACK REAGENT CARTRIDGES) Biotrack, Inc. JJQ Class I 1986-05-23
K861640 MODUMATIC (R) DILUTER Tri-Continent Scientific, Inc. JQW Class I 1986-05-23
K860935 EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95 Em Diagnostic Systems, Inc. CIJ Class II 1986-05-23
K861713 SERUM POTASSIUM REAGENT SET Sterling Diagnostics, Inc. CEJ Class II 1986-05-23
K861653 GLUCOSE HK PROCEDURE Data Medical Associates, Inc. CGA Class II 1986-05-23
K861185 THERACHEM-PLUS, TRI-LEVEL TDC (TM) Fisher Scientific Co., LLC JJY Class I 1986-05-23
K860942 QUANTIMETRIX HUMAN BILIRUBIN CONTROL I & II LIQUID Quantimetrix Corp. JJY Class I 1986-05-23
K861617 THE PARTNER SPECTROPHOTOMETER Pharmacia, Inc. JJQ Class I 1986-05-19
K855238 BIOTEL (TM)/UTI American Diagnostic Corp. JMT Class I 1986-05-09
K860987 MINI-CHEM ANALYZER Ocean Scientific, Inc. JJQ Class I 1986-05-05
K861146 MODEL K110SX CENTRIFUGE Jouan S.A. JQC Class I 1986-05-05
K860465 VISION SGOT (AST) - ADDIT. OF WHOLE BLOOD CLAIM Abbott Laboratories CIT Class II 1986-05-05
K861223 THE JR. PARTNER SPECTROPHOTOMETER Pharmacia, Inc. JJQ Class I 1986-05-05
K860945 DIRECTACLONE CG SLIDE PREGNANCY TEST Pacific Biotech, Inc. JHJ Class II 1986-05-02
K860508 POSID SAMPLER Organon Teknika Corp. JQW Class I 1986-05-02
K861010 VMA BY HPLC TEST (VANILMANDELIC ACID) Bio-Rad CDF Class I 1986-05-01
K861329 ISOTRAK AMYLASE ISOENZYME CONTROL SET Behring Diagnostics, Inc. JJT Class I 1986-04-30
K860984 TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT Hybritech, Inc. CEP Class I 1986-04-29
K861419 HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE Hi Chem, Inc. CFJ Class II 1986-04-28

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