meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
58
Latest Decision
1989-04-14

Clearances · page 74 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K890831 EMIT CONVENIENCE PACK: THYROXINE ASSAY Syva Co. KLI Class II 1989-04-14
K890319 URIC ACID KIT, CODES 4825400 AND 4825050 American Research Products Co. KNK Class I 1989-04-12
K890584 HI CHEM CALCIUM REAGENT #88808 Hichem Diagnostics CJY Class II 1989-04-10
K890698 ABBOTT ALT-ACTIVATED (LIQUID, LIST #01A55) Abbott Laboratories CKA Class I 1989-04-10
K890990 EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE Hichem Diagnostics CHH Class I 1989-04-10
K891117 HDL CHOLESTEROL REAGENT Pointe Scientific, Inc., LBR Class I 1989-04-10
K891286 BIOTROL CHEMISTRY URINE CONTROL Biotrol, USA, Inc. JJW Class I 1989-04-10
K891068 VENTREX COATED TUBE T3 UPTAKE Ventrex Laboratories, Inc. KHQ Class II 1989-04-10
K890873 GLUCOFILM TEST STRIPS & CONTROLS/GLUCOMETER 3 Heraeus Kulzer, Inc. CGA Class II 1989-04-04
K891469 ALT (GPT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT Trace Scientific , Ltd. CKA Class I 1989-04-04
K884176 CHROMATOGRAPHY KIT Gelman Sciences, Inc. DPA Class I 1989-04-04
K891025 TOTAL BILIRUBIN FOR CONTINUOUS FLOW Catachem, Inc. CIG Class II 1989-04-04
K890528 ROCHE CHLORIDE ELECTRODE Roche Diagnostic Systems, Inc. CGA Class II 1989-03-31
K890798 REVISED MAGNESIUM TEST ITEM NUMBER: SR1019 Em Diagnostic Systems, Inc. JGJ Class I 1989-03-31
K890929 KODAK EKTACHEM 750 SERIES ANALYZER Eastman Kodak Company JJE Class I 1989-03-28
K890927 KODAK EKTACHEM 500/750 SERIES ANALYZER, SOFT V1.0 Eastman Kodak Company JJE Class I 1989-03-28
K890802 COTUBE(TM) TSH IRMA Bio-Rad JLW Class II 1989-03-28
K890549 VENTREX COATED TUBE HCG Ventrex Laboratories, Inc. JHI Class II 1989-03-28
K885203 TECHNICON DAX(TM) SYSTEM Technicon Instruments Corp. JJG Class I 1989-03-28
K890997 ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC) Atlantic Wholesale, Inc. KEA Class I 1989-03-28
K885263 QMS(TM) - THEOPHYLLINE Seradyn, Inc. JQX Class I 1989-03-28
K891355 MAGNESIUM REAGENT Medical Analysis Systems, Inc. JGJ Class I 1989-03-28
K890928 KODAK EKTACHEM 500 ANALYZER Eastman Kodak Company JJE Class I 1989-03-28
K890908 STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES Baxter Healthcare Corp KHO Class I 1989-03-24
K890312 GAMMA-GLUTAMYLTRANSFERASE American Monitor Corp. JQB Class I 1989-03-24
K890510 ABBOTT OVULATION PREDICTOR TEST Abbott Laboratories CEP Class I 1989-03-24
K890573 KENLOR TOTAL IRON, UIBC/TIBC ASSAY KIT Kenlor Industries, Inc. JIY Class I 1989-03-24
K890521 ABBOTT CLINICAL CHEMISTRY REAGENT ALP Abbott Laboratories CJE Class II 1989-03-24
K885292 COBAS MFC Roche Diagnostic Systems, Inc. JQP Class I 1989-03-22
K891218 IQ/QCA PHOSPHORUS Bd Becton Dickinson Vacutainer Systems Preanalytic CEO Class I 1989-03-22
K890846 BIOTROL URINE PROTEINS REAGENT Biotrol, USA, Inc. JIR Class I 1989-03-21
K890868 DMA MICROPROTEIN PROCEDURE Data Medical Associates, Inc. CEK Class II 1989-03-20
K890708 AMERLITE REPRODUCTIVE ENDOCRINOLOGY (LABEL CHANGE) Amersham Corp. JJY Class I 1989-03-20
K883298 RECONDITIONED ASTRA (TM) 8 Associated Electro-Medical Services, Inc. JJF Class I 1989-03-16
K891154 SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B Atlantic Antibodies MSJ Class I 1989-03-16
K883350 RECONDITIONED ASTRA(TM) 4 Associated Electro-Medical Services, Inc. JJF Class I 1989-03-16
K890854 EIA READER MODEL EL301 Bio-Tek Instruments, Inc. JJQ Class I 1989-03-16
K890579 TSH MICROASSAY Diamedix Corp. JLW Class II 1989-03-16
K890836 RIA-GNOST PROGESTERONE Cambridge Medical Technology JLS Class I 1989-03-16
K890609 IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE) Intl. Immunoassay Laboratories, Inc. CGS Class II 1989-03-16
K890470 RIATRAC PLUS Bd Becton Dickinson Vacutainer Systems Preanalytic JJY Class I 1989-03-15
K883411 PG-NUMERIC(TM) Isolab, Inc. JHF Class II 1989-03-15
K890524 APEC GLUCOSE ANALYZER Amdev, Inc. CGA Class II 1989-03-15
K890414 RADIOASSAY CONTROLS 19,20,21,33,34 & 35 (QAS.109) Amersham Corp. JJY Class I 1989-03-15
K890543 IMPRES-MB REAGENT A AND REAGENT B Intl. Immunoassay Laboratories, Inc. JHX Class II 1989-03-13
K882538 PROGENE MICROALBUMINURIA SCREEN Progene Corp. JIR Class I 1989-03-13
K885078 LIPASE SR LIQUID STABLE REAGENT SET Medical Analysis Systems, Inc. CET Class I 1989-03-13
K890583 HI CHEM CALIBRATION STANDARDS LEVELS 1 AND 2 Hichem Diagnostics JIX Class II 1989-03-13
K890578 HI CHEM WASH CONCENTRATE REAGENT #88805 Hichem Diagnostics JQW Class I 1989-03-10
K884757 CLINISTAT CHOLESTEROL REAGENT TEST Heraeus Kulzer, Inc. CHH Class I 1989-03-10
K890278 TOTAL PROTEIN REAGENT Sigma Chemical Co. CEK Class II 1989-03-09
K890337 TRIGLYCERIDES - GPO REAGENT Alpkem Corp. CDT Class I 1989-03-09
K890577 KENLOR LIQUID URINE CONTROL Kenlor Industries, Inc. JJW Class I 1989-03-09
K890576 KENLOR HUMAN SPINAL FLUID CONTROL LIQUID Kenlor Industries, Inc. JJY Class I 1989-03-09
K890131 TARGET(TM) QUANTITATIVE HCG V-Tech, Inc. JHI Class II 1989-03-09
K890669 STATSPIN HDL-CHOLESTEROL PRECIPITATING MICRO TUBE Norfolk Scientific, Inc. LBR Class I 1989-03-08
K890317 TOTAL PROTEIN REAGENT Medical Analysis Systems, Inc. CEK Class II 1989-03-08
K884489 C&T PREGNANCY TEST KIT Healthcheck Corp. LCX Class II 1989-03-08
K884724 ASPARTATE AMINOTRANSFERASE (AST) Catachem, Inc. CIT Class II 1989-03-08
K890395 BIOTROL IRON REAGENT Biotrol, USA, Inc. JIY Class I 1989-03-08
K883814 DELFIA HLH SPEC KIT Pharmacia, Inc. CEP Class I 1989-03-08
K890645 ESTRADIOL MAIACLONE RADIOIMMUNOASSAY KIT Serono-Baker Diagnostics, Inc. CHP Class I 1989-03-08
K884809 DELFIA SHBG KIT Pharmacia, Inc. CDZ Class I 1989-03-08
K890442 SHAPE-ACTIO URINALYSIS CONTROLS Actio, Inc. JJY Class I 1989-03-08
K890534 MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1 Fisher Scientific Co., LLC JJW Class I 1989-03-08
K890269 ALKALINE PHOSPHATASE ISOENZYME REAGENTS Beckman Instruments, Inc. CIN Class II 1989-03-08
K890070 TOTAL BILIRUBIN REAGENT, CONCENTRATED Trace Scientific , Ltd. CIG Class II 1989-03-06
K890502 MICROLITE TUBE LUMINOMETER #011-902-0000 Dynatech Laboratories, Inc. JJQ Class I 1989-02-27
K890336 GLUCOSE (GOD) REAGENT Alpkem Corp. CGA Class II 1989-02-27
K890302 CALCIUM PLUS PROCEDURE Data Medical Associates, Inc. CJY Class II 1989-02-27
K890540 ABBOTT CLINICAL CHEMISTRY REAGENT CK-NAC Abbott Laboratories CGS Class II 1989-02-27
K884378 DACOS OR DACOS XL CLINICAL CHEMISTRY ANALYZER Coulter Corp. JJE Class I 1989-02-27
K884753 MODIFIED FREE T4 RADIOIMMUNOASSAY KIT Advanced Magnetics, Inc. CEC Class II 1989-02-27
K885198 17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA Icn Biomedicals, Inc. JLX Class I 1989-02-23
K890428 DELFIA PROGESTERONE KIT Pharmacia, Inc. JLS Class I 1989-02-23
K884550 CREATINE KINASE MB ENZYME IMMUNOASSAY KIT Bd Becton Dickinson Vacutainer Systems Preanalytic JHY Class II 1989-02-23
K890109 SAFEPETTE DISPENSER Safe-Tec Clinical Products, Inc. JKA Class II 1989-02-23
K885341 TITAN GEL ALKALINE PHOSPHATASE (HR) Helena Laboratories CIN Class II 1989-02-23
K884260 THYROXINE MICROASSAY Diamedix Corp. KLI Class II 1989-02-23
K884689 DSL 7800 ACTIVE CORTISOL Diagnostic Systems Laboratories, Inc. CGR Class II 1989-02-23
K890023 HDL CHOLESTEROL REAGENT (PTA/MGCL2) Sigma Diagnostics, Inc. LBR Class I 1989-02-17
K884782 MICROLITE CAMERA LUMINOMETER CL 1050 (0119010000) Dynatech Laboratories, Inc. JJQ Class I 1989-02-17
K885023 CHOLESTEROL TEST ITEM NUMBER: SR1011 Em Diagnostic Systems, Inc. CHH Class I 1989-02-17
K885258 ACA THYROXINE (T4 E) METHOD The DU Pont Co. KLI Class II 1989-02-17
K890332 RFA/2 RAPID FLOW ANALYZER W/COMPUTER Alpkem Corp. JJC Class I 1989-02-17
K890305 BICARBONATE TEST ITEM NUMBER: SR1006 Em Diagnostic Systems, Inc. KHS Class II 1989-02-17
K885141 EMIT THYROXINE ASSAY Syva Co. KLI Class II 1989-02-17
K885226 TECHNICON AXON(TM) SYSTEM Technicon Instruments Corp. JJE Class I 1989-02-17
K890335 SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU. Alpkem Corp. CGE Class II 1989-02-17
K885259 ACA THYRONINE UPTAKE (TU E) METHOD The DU Pont Co. KHQ Class II 1989-02-17
K885024 ALKALINE PHOSPHATASE ISOENZYME SYSTEM Ciba Corning Diagnostics Corp. CIN Class II 1989-02-17
K885176 AMYLASE SR LIQUID STABLE REAGENT SET Medical Analysis Systems, Inc. JFJ Class II 1989-02-17
K890015 BIOTROL CHLORIDE Biotrol, USA, Inc. CHJ Class II 1989-02-17
K885340 AIR DISPLACEMENT PIPETTE Ulster Scientific, Inc. JQW Class I 1989-02-14
K885265 HDL CHOLESTEROL TEST Em Diagnostic Systems, Inc. LBR Class I 1989-02-10
K885094 BIOTROL ALBUMIN Biotrol, USA, Inc. CIX Class II 1989-02-10
K885134 CLINISTAT TRIGLYCERIDES REAGENT TEST Heraeus Kulzer, Inc. JGY Class I 1989-02-10
K884771 IL PHOENIX, MODEL 900, CHEMISTRY/ELECTROLYTE ANALY Instrumentation Laboratory CO JFP Class II 1989-02-10
K885157 VENTREX COATED TUBE HIGH SENSITIVITY TSH Ventrex Laboratories, Inc. JLW Class II 1989-02-10
K890135 IMX FOLLICLE STIMULATING HORMONE (FSH) Abbott Laboratories CGJ Class I 1989-02-10

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