meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
62
Latest Decision
1994-04-20

Clearances · page 55 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K940570 SYNERMED TOTAL BILIRUBIN REAGENT KIT Synermed, Inc. CIG Class II 1994-04-20
K940272 ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL Analytical Control Systems, Inc. JJX Class I 1994-04-20
K936184 VIGIL PRX CHEMISTRY CONTROL Beckman-Diagnostic Systems Group JJY Class I 1994-04-15
K936031 ONE STEP PREGNANCY TEST Teco Diagnostics JHI Class II 1994-04-15
K934124 AUTOQUOT AUTOMATED ALIQUOTTING SYSTEM Andronic Devices, Ltd. JQW Class I 1994-04-13
K940043 BIOSCAN REAGENT STRIPS Bioscan Instruments, Inc. JIL Class II 1994-04-12
K933682 DIRECT AMYLASE (EC 3.2.1.1) METHOD FOR TECHNICON SYSTEMS Miles, Inc. JFJ Class II 1994-04-12
K925468 JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KIT J.J. Skinner, Inc. GJE Class II 1994-04-11
K936138 KODAK SURECELL HCG-SERUM/URINE TEST KIT, MODIFICATION Eastman Kodak Company JHI Class II 1994-04-08
K936287 KODAK SURECELL HCG URINE TEST, MODIFICATION Eastman Kodak Company JHI Class II 1994-04-08
K935119 RADIAS 3RD GENERATION TSH IMMUNOASSAY Bio-Rad JLW Class II 1994-04-06
K934841 URINARY/CEREBROSPINAL FLUID PROTEIN E.I. Dupont DE Nemours & Co., Inc. CEK Class II 1994-04-06
K930678 AMYLASE Horizon Diagnostics, Inc. JFJ Class II 1994-04-06
K934592 EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR Abaxis, Inc. JJG Class I 1994-04-06
K940549 ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY Bio-Rad Laboratories, Inc. CEP Class I 1994-04-06
K940568 DOCUMENT(R) ZERO Casco Standards JJX Class I 1994-04-05
K940194 SYNERMED ISE REAGENTS Synermed, Inc. JGS Class II 1994-04-05
K930534 TMC I, II Ciba Corning Diagnostics Corp. JJY Class I 1994-04-04
K934607 ALKO REAGENTS FOR BAXTER PARAMAX CHEMISTRY SYSTEM Alko Diagnostic Corp. JIX Class II 1994-03-28
K935069 IL1430 BGELECTROLYTE ANALYZER Instrumentation Laboratory CO CHL Class II 1994-03-28
K931116 IL TEST(TM) TRIGLYCERIDE Instrumentation Laboratory CO JGY Class I 1994-03-28
K935816 VIDAS T UPTAKE Biomerieux Vitek, Inc. KHQ Class II 1994-03-22
K934764 VIDAS T3 ASSAY Biomerieux Vitek, Inc. CDP Class II 1994-03-22
K935469 SYNELISA DHEA-SULFATE Elias U.S.A., Inc. JKC Class I 1994-03-22
K935219 FERTILITY PLUS 1, 2, 3 Ciba Corning Diagnostics Corp. JJY Class I 1994-03-22
K935543 ACA PLUS FERRITIN CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. JIX Class II 1994-03-22
K935606 SERUM AMMONIA CONTROL P.T. Meditrol JJX Class I 1994-03-22
K934071 KODAK EKTACHEM DT SLIDES (URCR) Eastman Kodak Company CGX Class II 1994-03-21
K934358 KODAK EKTACHEM DT SLIDES (FE) Eastman Kodak Company JQE Class I 1994-03-21
K933678 SIGMA CALCIUM REAGENT Sigma Chemical Co. CJY Class II 1994-03-11
K940010 DMA AMYLASE (DEMAND) PROCEDURE Data Medical Associates, Inc. CIJ Class II 1994-03-11
K934843 URINARY/CEBROSPINAL FLUID PROTEIN CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. JIT Class II 1994-03-11
K934587 CREATININE-S ASSAY Diagnostic Chemicals , Ltd. CGX Class II 1994-03-11
K940397 ACS O DILVENT PROTEIN DILUTION MATRIX Analytical Control Systems, Inc. JJY Class I 1994-03-11
K936201 URINARY ALBUMIN CALIBRATOR Dupont Medical Products JIS Class II 1994-03-11
K933383 REAGENTS FOR HITACHI ISE Alko Diagnostic Corp. JIX Class II 1994-03-09
K934137 OPUS(R) SEROLOGY CONTROLS, MODIFICATION Pb Diagnostic Systems, Inc. MJX Class I 1994-03-07
K940005 ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY Bio-Rad Laboratories, Inc. CGJ Class I 1994-03-03
K935880 CEDIA T4 MAB ASSAY MODIFICATION Microgenics Corp. KLI Class II 1994-03-03
K936013 EVATEST STRIP Boehringer Mannheim Italia Spa LCX Class II 1994-02-25
K923917 ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY Nuclear Diagnostics, Inc. CHI Class I 1994-02-25
K933088 PLATO 3000 Rosys, Inc. JQW Class I 1994-02-25
K935863 SAS(TM) DIRECT MONOCLONAL HCG Sa Scientific, Inc. JHJ Class II 1994-02-24
K934516 ADVANCE PREGNANCY TEST MODIFICATION Ortho Pharmaceutical Corp. LCX Class II 1994-02-24
K936081 I-STAT TESTS FOR ACID-BASE PARAMETERS I-Stat Corp. CHL Class II 1994-02-24
K935286 QUANTAPHASE II B12/FOLATE Bio-Rad CGN Class II 1994-02-18
K934588 CHLORIDE (MF) ASSAY Diagnostic Chemicals , Ltd. CHG Class II 1994-02-18
K933218 REFRACTOMETRIC, TOTAL PROTEIN Pyramid Biological Corp. JJX Class I 1994-02-17
K922343 TRI-TECH INC. CUSTOM SEXUAL ASSAULT KIT Tri-Tech, Inc. JKA Class II 1994-02-17
K933401 THE BUCK Medical Implements, Inc. JKA Class II 1994-02-10
K933939 BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT Organon Teknika Corp. GIM Class II 1994-02-07
K932852 NON INVASIVE VASCULAR PROGRAM D. E. Hokanson, Inc. JOB Class I 1994-02-04
K935830 CIBA CORNING 248 PH/BLOOD GAS ANALYZER Ciba Corning Diagnostics Corp. CHL Class II 1994-02-03
K931362 IL TEST CALCIUM Instrumentation Laboratory CO CIC Class II 1994-02-01
K932888 INTERSECT SYSTEMS DIRECT AMYLASE REAGENT Intersect Systems, Inc. JFJ Class II 1994-01-31
K935362 P-AMYLASE CONTROL Beckman JJX Class I 1994-01-27
K931701 IMMULITE PAP Diagnostic Products Corp. JFH Class II 1994-01-27
K935502 EVENT TEST STRIP HCG Boehringer Mannheim Italia Spa JHI Class II 1994-01-27
K935062 MAS LIQUID URINALYSIS CONTROL Medical Analysis Systems, Inc. JJW Class I 1994-01-27
K935181 ASPARTATE AMINOTRANSFERASE (AST) TEST Em Diagnostic Systems, Inc. CIT Class II 1994-01-27
K932607 COBAS(R) CORE FT4 EIA Roche Diagnostic Systems, Inc. CEC Class II 1994-01-24
K932605 COBAS (R) CORE T4 EIA Roche Diagnostic Systems, Inc. KLI Class II 1994-01-24
K935547 CAL 1 AND CAL 2 STANDARDS/STANDARDS FOR IL 501 SODIUM/POTASSIUM ANALYZER Alko Diagnostic Corp. JIX Class II 1994-01-18
K935018 REAGENTS FOR ORION 1020, AND RELATED ANALYZERS Alko Diagnostic Corp. JIX Class II 1994-01-18
K932368 UROPAPER EIKEN 6B Tanabe U.S.A., Inc. JIL Class II 1994-01-13
K935180 ALANINE AMINOTRANSFERASE (ALT) TEST Em Diagnostic Systems, Inc. CKA Class I 1994-01-13
K925464 CALIBRATION SOLUTIONS FOR USE ON ELECTROLYTE INSTR Alko Diagnostic Corp. JIX Class II 1994-01-13
K930231 ALKO CALIBRATION FOR AMDEV LYTENING SYSTEMS Alko Diagnostic Corp. JIX Class II 1994-01-13
K925385 REAGENTS FOR ABBOTT SPECTRUM/EPX (ELECTRO CALIBRA) Alko Diagnostic Corp. JIX Class II 1994-01-13
K930199 ALKO FLUIDS PACKS FOR NOVA ANALYZERS Alko Diagnostic Corp. JIX Class II 1994-01-13
K935134 ONE STEP LH TEST Tcpi, Inc. CEP Class I 1994-01-11
K930810 TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY Hybritech, Inc. CIN Class II 1994-01-11
K935138 IMMULITE PROGESTERONE Diagnostic Products Corp. JLS Class I 1994-01-11
K934146 N-ASSAY TIA MICROALBUMIN Crestat Diagnostics, Inc. JIR Class I 1994-01-11
K935081 DIRECTDRAW SUPERSERUM-MINI International Technidyne Corp. JKA Class II 1994-01-11
K934977 MODEL 5500 CEAS Esa, Inc. CDF Class I 1994-01-11
K934892 RELIEF PLUS ONE REAGENT STRIP MODIFICATION Diagnostic Solutions, Inc. CGA Class II 1994-01-11
K935463 CREATINE KINASE-MB (CK-MB) REAGENT SET Pointe Scientific, Inc., CGS Class II 1994-01-11
K932926 IMMULITE ESTRADIOL Diagnostic Products Corp. CHP Class I 1994-01-10
K934751 ACTIVE ANDROSTANEDIOL GLUCURONIDE Diagnostic Systems Laboratories, Inc. CIZ Class I 1994-01-10
K923504 CHOLESTEROL ENZYMATIC ENDPOINT Randox Laboratories, Ltd. CHH Class I 1994-01-10
K921868 ENDOCRINE SCIENCES PRODUCTS IGFBP3 RADIOIMMUNO KIT Endocrine Sciences Products CFL Class I 1994-01-03
K933696 SIGMA ELECTROLYTE REFERENCE REAGENT Sigma Chemical Co. JFL Class II 1994-01-03
K935287 IRON -II (FE-II) METHOD/TECH CHEM 1(R) 1+TM SYSTEM Miles, Inc. JIY Class I 1994-01-03
K934907 860 MEASURMENT SYSTEM Ciba Corning Diagnostics Corp. CHL Class II 1994-01-03
K934922 CLEARVIEW POSITIVE AND NEGATIVE HCG URINE CONTROL SET Unipath , Ltd. JJX Class I 1993-12-29
K934923 CLEARVIEW POSITIVE AND NEGATIVE URINE HCG CONTOL SET Unipath , Ltd. JJX Class I 1993-12-29
K933844 PARA 4 PLUS Streck Laboratories, Inc. JJY Class I 1993-12-27
K935178 EMDS PHOSPHOROUS (PHOS) TEST Em Diagnostic Systems, Inc. CEO Class I 1993-12-17
K933691 SIGMA CO2 ALKALINE BUFFER REAGENT Sigma Chemical Co. JFL Class II 1993-12-17
K934642 I-STAT IONIZED CALCIUM TEST I-Stat Corp. JFP Class II 1993-12-17
K935179 EMDS ALBUMIN (ALB) TEST Em Diagnostic Systems, Inc. CIX Class II 1993-12-17
K933679 SIGMA BUN REAGENT Sigma Chemical Co. LFP Class II 1993-12-17
K935174 TOTAL PROTEIN TEST (TPRO) Em Diagnostic Systems, Inc. CEK Class II 1993-12-16
K935175 LACTATE DEHYDROGENASE (LD) Em Diagnostic Systems, Inc. CFJ Class II 1993-12-16
K935136 CHOLESTEROL (CHOL) TEST ITEM NO. 65410 Em Diagnostic Systems, Inc. CHH Class I 1993-12-16
K935177 GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST Em Diagnostic Systems, Inc. JQB Class I 1993-12-16
K935176 IRON TEST Em Diagnostic Systems, Inc. JIY Class I 1993-12-16
K933703 SIGMA WASH CONCENTRATE SOLUTION Sigma Chemical Co. JJE Class I 1993-12-10
K934562 CIBA CORNING ACS TESTOSTERONE IMMUNOASSAY Ciba Corning Diagnostics Corp. CDZ Class I 1993-12-10

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