meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
62
Latest Decision
1988-03-24

Clearances · page 79 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K880710 PROTEIN BASE ISE CONTROL Bionostics, Inc. JJR Class I 1988-03-24
K880296 LUMATAG(TM) PROLACTIN CHEMILUMINES. IMMUNO. ASSAY London Diagnostics, Inc. CFT Class I 1988-03-24
K880701 QUANTIMETRIX SERUM ENZYME CONTROL Quantimetrix Corp. JJT Class I 1988-03-24
K880610 UNIMETER CALIBRATION KIT Boehringer Mannheim Corp. JIW Class II 1988-03-24
K880677 TOTAL PROTEIN REAGENT SET Tech-Neal Scientific, Inc. CEK Class II 1988-03-24
K880313 WAKO(TM) AUTOKIT ALBUMIN Wako Chemicals USA, Inc. CIX Class II 1988-03-24
K880467 STANBIO CAB TOTAL IRON PROCEDURE, LIQUICOLOR Stanbio Laboratory JIY Class I 1988-03-24
K880546 TOTAL IRON BINDING CAPACITY (TIBC) Boehringer Mannheim Corp. JMO Class I 1988-03-24
K880651 PARAMAX AMMONIA REAGENT Baxter Healthcare Corp JIF Class I 1988-03-24
K880620 EMIT THYROXINE ASSAY Syva Co. KLI Class II 1988-03-24
K880629 CREATININE Tech-Co, Inc. CGX Class II 1988-03-23
K880609 ANALYTE CARBON DIOXIDE ASSAYED ON TECHNICON RA(TM) Technicon Instruments Corp. KHS Class II 1988-03-16
K880496 LYPHOCHEK QUANTITATIVE URINE CONTROL NORMAL (1) Bio-Rad JJW Class I 1988-03-16
K880630 LACTATE DEHYDROGENASE (LDH-L) Tech-Co, Inc. CFH Class II 1988-03-16
K880662 VISION(R) THYROXINE (T4) Abbott Laboratories KLI Class II 1988-03-16
K880242 KONE CALCIUM TEST The Rupp & Bowman Co. CJY Class II 1988-03-15
K880238 TRIGLYCERIDE Tech-Neal Scientific, Inc. CDT Class I 1988-03-15
K880090 ION TRAP DETECTOR Finnigan Corp. DOP Class I 1988-03-15
K880236 GLUCOSE HEXOKINASE Tech-Neal Scientific, Inc. CFR Class II 1988-03-15
K880395 TOTAL BILIRUBIN PROCEDURE RUN ON A DEMAND INSTRU. Data Medical Associates, Inc. CIG Class II 1988-03-15
K880307 ALKALINE PHOSPHATASE REAGENT SET Tech-Neal Scientific, Inc. CJE Class II 1988-03-15
K880268 CO2 REAGENT Sigma Diagnostics, Inc. KHS Class II 1988-03-15
K880628 TRIGLYCERIDES (GPO-TRINDER) Tech-Co, Inc. CDT Class I 1988-03-15
K880577 CONCEP-7-BHCG Leeco Diagnostics, Inc. JHI Class II 1988-03-15
K880495 LYPHOCHEK QUANTITATIVE URINE CONTROL ABNORMAL (2) Bio-Rad JJW Class I 1988-03-15
K880787 EASY-TEST LACTIC ACID (LA) Diagnostic Systems KHP Class I 1988-03-15
K880328 HCG-NOSTICK Organon Teknika Corp. JHJ Class II 1988-03-15
K880397 DIRECT BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU. Data Medical Associates, Inc. CIG Class II 1988-03-15
K880396 TOTAL BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU. Data Medical Associates, Inc. CIG Class II 1988-03-15
K875098 CIBA CORNING MODEL 644 Ciba Corning Diagnostics Corp. JXR Class I 1988-03-03
K874846 GLUCOSE (HEXOKINASE) Tech-Co, Inc. CFR Class II 1988-03-03
K880276 AST (SGOT) REAGENT SET Tech-Neal Scientific, Inc. CIT Class II 1988-03-03
K880388 T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE Serono Diagnostics, Inc. CDP Class II 1988-03-03
K880494 LYPHOCHEK SPINAL FLUID CONTROL (HUMAN) Bio-Rad JJY Class I 1988-03-03
K880311 WAKO(TM) AUTOKIT CHOLESTEROL Wako Chemicals USA, Inc. CHH Class I 1988-03-01
K880344 IQ ALKALINE PHOSPHATASE Bd Becton Dickinson Vacutainer Systems Preanalytic CJK Class II 1988-03-01
K880275 ALT (SGPT) REAGENT SET Tech-Neal Scientific, Inc. CKA Class I 1988-03-01
K875131 (SKD) CHOLESTEROL TEST KIT Smithkline Diagnostics, Inc. CHH Class I 1988-03-01
K880218 BINAX PROLACTIN IRMA DIAGNOSTIC KIT Binax, Inc. CFT Class I 1988-03-01
K880175 DADE(R) CK/LD COMPREHENSIVE ELECTRO. CONTROL Baxter Healthcare Corp JJY Class I 1988-03-01
K880339 EASY-TEST POTASSIUM K ITEM NUMBER 19XXX Em Diagnostic Systems, Inc. CEJ Class II 1988-02-25
K875248 BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS Bioscan Instruments, Inc. JMT Class I 1988-02-24
K880039 AMMONIA CONTROLS LOW AND HIGH #A 5565 & A 6665 Sigma Diagnostics, Inc. JJX Class I 1988-02-24
K875173 KODAK EKTACHEM DT SLIDES (LIPA) Eastman Kodak Company CHI Class I 1988-02-24
K875192 KODAK EKTACHEM DT SLIDES (CKMB) Eastman Kodak Company JHY Class II 1988-02-24
K875191 KODAK EKTACHEM DT SLIDES (CRSC) Eastman Kodak Company JFY Class II 1988-02-24
K880176 HDL CHOLESTEROL PRECIPITATING REAGENT Tech-Co, Inc. LBR Class I 1988-02-18
K875071 ASPARTATE AMINOTRANSFERASE AST/SGOT Tech-Co, Inc. CIT Class II 1988-02-18
K873550 DSL ACTIVE ESTRADIOL RIA (DSL #4300) Diagnostic Systems Laboratories, Inc. CHP Class I 1988-02-18
K874731 LYPHOCHEK WHOLE BLOOD CONTROL Bio-Rad JJY Class I 1988-02-18
K880178 CREATINE KINASE (COLORIMETRIC METHOD) Tech-Co, Inc. JHY Class II 1988-02-18
K874362 AMERLITE T3U ASSAY LAN.0004/1004/2004, 240/480/144 Amersham Corp. KHQ Class II 1988-02-18
K880266 MULTI-ENZYME LINEARITY SOLUTION Verichem Laboratories, Inc. JJT Class I 1988-02-18
K875282 QM300 CALIBRATOR B PACK Kallestad Diag, A Div. of Erbamont, Inc. JIX Class II 1988-02-17
K874623 FIAGEN(TM) THYROXINE (T4), CATALOGUE #101-101 Cyberfluor, Inc. CDX Class II 1988-02-16
K875105 TECHNICON SMAC 3 SYSTEM Technicon Instruments Corp. JJC Class I 1988-02-16
K874832 NOVA STAT PROFILE 5 ANALYZER + QUALITY CONTROL Nova Biomedical Corp. JGS Class II 1988-02-11
K874496 CALCIUM ASSAY KIT, NUMBER 120-19 Diagnostic Chemicals, Ltd. (Usa) CIC Class II 1988-02-11
K880089 FINNIGAN MAT TSQ-70 Finnigan Corp. DOP Class I 1988-02-11
K874918 IRON PROCEDURE Data Medical Associates, Inc. JIY Class I 1988-02-11
K875081 IMMPULSE T4 ASSAY REAGENTS Sclavo, Inc. CDX Class II 1988-02-11
K874782 COAT-A-COUNT NEONATAL 17-ALPHA HYDROXPROG RIA KIT Diagnostic Products Corp. JLX Class I 1988-02-11
K880078 UREA NITROGEN (BUN) Tech-Neal Scientific, Inc. CDQ Class II 1988-02-11
K880069 LEECO PREGNASTICK (EIA) CATALOG #003 Leeco Diagnostics, Inc. LCX Class II 1988-02-11
K874903 MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT) Simmler, Inc. JPZ Class I 1988-02-11
K874866 T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE Serono Diagnostics, Inc. KLI Class II 1988-02-11
K874388 KODAK SURECELL(TM) HCG-URINE KIT Eastman Kodak Company JHI Class II 1988-02-08
K874857 KODAK EKTACHEM 700 ANALYZER FAMILY, SOFTWARE V4.0 Eastman Kodak Company JJE Class I 1988-02-08
K875263 ANALYTES SODIUM & POTASSIUM ASSAYED ON TECH RA(R) Technicon Instruments Corp. JGS Class II 1988-02-08
K875304 BIOTROL CALIBRANT LEVEL 2 Biotrol, USA, Inc. JIX Class II 1988-02-03
K875262 V-TREND BETA-HCG DRY-SPOT TEST Texas Immunology, Inc. JHJ Class II 1988-02-02
K875176 WAKO(TM) UIBC Wako Chemicals USA, Inc. JQF Class I 1988-02-02
K875210 ALKALINE PHOSPHATASE CAT. # 306-22, 306-23 Diagnostic Chemicals, Ltd. (Usa) CJE Class II 1988-02-02
K875206 LACTATE DEHYDROGENASE CAT. # 320-68, 320-69 Diagnostic Chemicals, Ltd. (Usa) CFJ Class II 1988-02-02
K873986 BETA-HCG ASSAY Schiff & Co. DHA Class II 1988-02-02
K875288 BIOTROL CALIBRANT LEVEL 1 Biotrol, USA, Inc. JIX Class II 1988-02-02
K875318 BIOTROL CALIBRANT LEVEL 3 Biotrol, USA, Inc. JIX Class II 1988-02-02
K874087 MODIFIED CALCITONIN RIA KIT DSL #1200 Diagnostic Systems Laboratories, Inc. JKR Class II 1988-02-02
K874302 QUANTIMETRIX TOTAL CREATINE KINASE CONTROL Quantimetrix Medical Industries JJT Class I 1988-02-02
K872843 OVEIA (TM) DUAL ANALYTE Boots-Celltech Diagnostics, Inc. JLP Class I 1988-02-02
K870708 GLUCOSCOT II BLOOD GLUCOSE TEST SYSTEM Kyoto Daiichi Kagaku Co., Ltd. LFR Class II 1988-02-02
K875209 ACID PHOSPHATASE (KINETIC) CAT. # 320-06 Diagnostic Chemicals, Ltd. (Usa) CKB Class II 1988-02-01
K875320 BIOTROL URIC ACID ENZYMATIQUE UV H.P. Biotrol, USA, Inc. CDO Class I 1988-02-01
K873726 ACID PHOSPHATASE TEST King Diagnostics, Inc. CKE Class II 1988-01-27
K874506 USE OF TECHNICON RA SYSTEMS REAGENTS ON ASSIST(R) Technicon Instruments Corp. JGJ Class I 1988-01-22
K875222 TOTAL PROTEIN Catachem, Inc. CEK Class II 1988-01-22
K874822 RAICHEM(TM) MAGNESIUM REAGENT Reagents Applications, Inc. JGJ Class I 1988-01-21
K874890 QUANTIMETRIX URINE DIPSTICK CONTROL Quantimetrix Medical Industries JJW Class I 1988-01-21
K874586 EASY-TEST ALANINE AMINOTRANSFERASE (ALAT) #19017 Em Diagnostic Systems, Inc. CKA Class I 1988-01-21
K873366 WAKO(TM) PRETEST 5A Wako Chemicals USA, Inc. CDM Class I 1988-01-21
K874638 V-TREND BETA-HCG TEST Texas Immunology, Inc. JHJ Class II 1988-01-21
K874284 SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM Diagnostic Chemicals, Ltd. (Usa) JHT Class II 1988-01-21
K874576 KODAK EKTACHEM DT SLIDES (MG) Eastman Kodak Company JGJ Class I 1988-01-21
K874595 MULTICHEM (R) MAGNESIUM REAGENT Simmler, Inc. JGJ Class I 1988-01-21
K874835 PYRIDOXAL-5-PHOSPHATE TABLETS Boehringer Mannheim Corp. CKA Class I 1988-01-21
K874824 CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY Supelco, Inc. DII Class I 1988-01-21
K874584 TRIGLYERIDES TEST KIT Ciba Corning Diagnostics Corp. CDT Class I 1988-01-21
K874600 EASY-TEST ASPARTATE AMINOTRANSFERASE (ASAT) #19010 Em Diagnostic Systems, Inc. CIT Class II 1988-01-21
K874280 LYPHOCHEK ASSAYED CHEMISTRY CONTROL (HUMAN), I/II Bio-Rad JJY Class I 1988-01-21
K874187 A-GENT TRIGLLYCERIDES GPO Abbott Laboratories CDT Class I 1988-01-21

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