meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
58
Latest Decision
1991-06-20

Clearances · page 65 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K912241 STRATUS(R) HTSH FLUORMETRIC ENZYME IMMUNOASSAY Baxter Healthcare Corp JLW Class II 1991-06-20
K911839 NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT Pantex, Div. Bio-Analysis, Inc. JLX Class I 1991-06-18
K912321 MODULE: NOVA NUCLEUS TMG MODULE FLUID PACK Nova Biomedical Corp. JGJ Class I 1991-06-17
K911984 ANEMIA I, II Ciba Corning Diagnostics Corp. JJY Class I 1991-06-13
K912016 IL PHOENIX(TM), MODEL 905 CHEM/ELECT ANALYZER Instrumentation Laboratory CO JGS Class II 1991-06-10
K912055 SYVA EDMS Syva Co. JJF Class I 1991-06-10
K911854 DADE LIID-TROL TL TRI-LEVEL LIPID CONTROL Baxter Healthcare Corp JJY Class I 1991-06-10
K912228 MARK 5 ROBOTIC PIPETTOR Diagnostic Products Corp. JQW Class I 1991-06-06
K911248 SYNERMED UREA NITROGEN REAGENT KIT Synermed, Inc. CDQ Class II 1991-06-03
K911664 DIRECTIGEN 1-2-3 PREGNANCY CONTROLS Quidel Corp. JJX Class I 1991-05-31
K911396 SR1 ESTRADIOL ENZYME IMMUNOASSAY Serono-Baker Diagnostics, Inc. CHP Class I 1991-05-28
K910837 SRI TSH IMMUNENZYMETRIC ASSAY Serono-Baker Diagnostics, Inc. JLW Class II 1991-05-24
K911438 TURBO ACCELERATOR W/CLIN DIAG SOFTWARE CARTRIDGE Bio-Tek Instruments, Inc. JJQ Class I 1991-05-23
K911092 OSMOMETER MODEL 2400 Advanced Instruments, Inc. JJM Class I 1991-05-22
K911512 MILENIA PROGESTERONE Diagnostic Products Corp. JLS Class I 1991-05-22
K911755 CONTROL FOR PH,BLOOD GASES,ELETROLYTES,GLUCOSE Bionostics, Inc. JJY Class I 1991-05-22
K910178 ACTH IRMA KIT MITSUBISHI YUKA Science Regulatory Services Intl. CKG Class II 1991-05-22
K911406 HDL CHOLESTEROL REAGENT Genzyme Corp. LBR Class I 1991-05-22
K911803 HI CHEM AQUEOUS MULTIANALYTE LINE STAND, MODIFIED Hichem Diagnostics JJY Class I 1991-05-15
K910635 TOTAL BILIRUBIN REAGENT SET Biochemical Trade, Inc. CIG Class II 1991-05-15
K911792 FIRST CHOICE(TM), MODIFICATION Polymer Technology Corp. CGA Class II 1991-05-15
K905741 CLEARVIEW HCG SERUM/URINE Unipath , Ltd. JHI Class II 1991-05-15
K911578 CHOLESTECH L.D.X. LIPID ANALYZER, MODIFICATION Cholestech Corp. CHH Class I 1991-05-15
K911596 VISION BG MONITOR British-American Medical, Inc. CGA Class II 1991-05-15
K911712 STRATUS(R) AUTOMATED SAMPLE HANDLER Baxter Healthcare Corp JQW Class I 1991-05-15
K910440 DOCUMENT REFLECTANCE II LINEARITY TEST SET Casco Standards JJY Class I 1991-05-10
K910646 SUPERSERUM REAGENT (SSR) International Technidyne Corp. JKA Class II 1991-05-10
K905658 SYSTEMATE CREATININE (EPOS APPLICATION) #65413 Em Diagnostic Systems, Inc. CGX Class II 1991-05-08
K911141 HEMOCUE(R) B-GLUCOSE MICROCUVETTE/PHOTOMETER Hemocue, Inc. CGA Class II 1991-05-08
K910552 ROCHE REAGENT FOR APOLIPOPROTEIN B Roche Diagnostic Systems, Inc. MSJ Class I 1991-05-07
K910551 ROCHE REAGENT FOR APOLIPOPROTEIN A-1 Roche Diagnostic Systems, Inc. MSJ Class I 1991-05-07
K911566 CLEARBLUE EASY Unipath , Ltd. LCX Class II 1991-05-06
K910721 BIOTROL PROTEIN MULTILEVEL STANDARDS Biotrol, USA, Inc. JIS Class II 1991-05-06
K911177 ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL II Analytical Control Systems, Inc. JJX Class I 1991-05-01
K911169 ACS THERAPEUTIC DRUG MONIT CONTR, SET II, LEVEL I Analytical Control Systems, Inc. JJY Class I 1991-05-01
K911170 THERAPEUTIC DRUG MONIT CONTROL, SET II, LEVEL II Analytical Control Systems, Inc. JIY Class I 1991-05-01
K910684 CIBA CORNING ACS FT4 IMMUNOASSAY Ciba Corning Diagnostics Corp. CEC Class II 1991-05-01
K911178 ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL III Analytical Control Systems, Inc. JJX Class I 1991-05-01
K911176 ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL I Analytical Control Systems, Inc. JJX Class I 1991-05-01
K911171 ACS THERAPEUTIC DRUG MONIT CONTR, SET II LEVEL III Analytical Control Systems, Inc. JJY Class I 1991-05-01
K910737 SRI T3 IMMOENZYMETRIC ASSAY Serono-Baker Diagnostics, Inc. CDP Class II 1991-05-01
K910981 CIBA CORNING ACS TSH IMMUNOASSAY Ciba Corning Diagnostics Corp. JLW Class II 1991-04-30
K910158 AMYLASE Pointe Scientific, Inc., JFJ Class II 1991-04-30
K910672 J&S PEDIATRIC IRON SATURATING REAGENT J.S. Medical Assoc. JQE Class I 1991-04-29
K911093 CIBA CORNING ACS T UPTAKE IMMUNOASSAY Ciba Corning Diagnostics Corp. KHQ Class II 1991-04-29
K910677 IMMULITE(TM) T-UPTAKE Cirrus Diagnostics, Inc. CEE Class II 1991-04-29
K910593 ROCHE REAGENT FOR DIRECT BILIRUBIN Roche Diagnostic Systems, Inc. CIG Class II 1991-04-24
K910591 ROCHE REAGENT FOR TOTAL BILIRUBIN Roche Diagnostic Systems, Inc. CIG Class II 1991-04-24
K904783 DISCRETE PHOTOMETRIC CHEMISTRY ANALYSER Industrial Chemical Measurement JJQ Class I 1991-04-18
K911468 REP SPE PLUS (ACID BLUE) SYSTEM Helena Laboratories CEF Class I 1991-04-16
K910261 IMMULITE(TM) TOTAL T4 Cirrus Diagnostics, Inc. KLI Class II 1991-04-16
K911297 CHLORIDE REAGENT Intersect Systems, Inc. CHJ Class II 1991-04-16
K911409 OPUS FSH Pb Diagnostic Systems, Inc. CGJ Class I 1991-04-16
K911050 LH IRMA IMMUNOMAG Pantex, Div. Bio-Analysis, Inc. CEP Class I 1991-04-12
K910639 SYSTEMATE ALKALINE PHOSPHATASE(EPOS APPL) #65483 Em Diagnostic Systems, Inc. CJE Class II 1991-04-12
K910640 SYSTEMATE LACTATE DEHYDROGENASE (EPOS APPL) #65476 Em Diagnostic Systems, Inc. CFJ Class II 1991-04-12
K904752 CHEMSTRIP(R) MICRAL(TM) URINE TEST STRIPS Boehringer Mannheim Corp. JIR Class I 1991-04-12
K910633 YSI MODEL 1500 BLOOD GLUCOSE ANALYZER Yellow Springs Instrument Co., Inc. CGA Class II 1991-04-12
K910534 SYNCHRON LACTATE REAGENT Beckman Instruments, Inc. KHP Class I 1991-04-08
K910683 ENZYMUN-TEST PROGESTERONE Boehringer Mannheim Corp. JLS Class I 1991-04-08
K911299 EQUIPMENT/MATERIAL DECONTAMINATING KIT Rohm and Haas Co. KIE Class I 1991-04-08
K911121 CIBA CORNING ACS CKMB IMMUNOASSAY Ciba Corning Diagnostics Corp. JHX Class II 1991-04-03
K910411 MICROZYME TSH ENZYME IMMUNOASSAY KIT Immunotech Corp. JLW Class II 1991-04-03
K910255 FLOW CYTOMETRY FITC/PE COMPENSATION KIT Sigma Diagnostics, Inc. JIW Class II 1991-04-03
K910305 GEM-PREMIER SYSTEM Mallinckrodt Sensor Systems, Inc. JGS Class II 1991-04-03
K910573 GLUCOSE V Caro Med, Inc. CGA Class II 1991-04-03
K910185 SYNCHRON CX4, CX5, AND CX7 CLINICAL ANALYZER Beckman Instruments, Inc. JJE Class I 1991-04-03
K910946 CLEARVIEW HCG Unipath , Ltd. JHJ Class II 1991-04-01
K910309 PARAMAX(R) ELECTROLYTE CALIBRATOR 1&2/MODIFICATION Baxter Healthcare Corp JIX Class II 1991-03-29
K910692 BIO SCAN-BG(TM Bio Scan Instrument, Inc. CGA Class II 1991-03-29
K910962 CHOLESTEROL CALIBRATOR SET Casco Standards JIT Class II 1991-03-29
K910740 SLT MICROPLATE WASHER Tecan U.S., Ltd. JJQ Class I 1991-03-27
K910351 MINICLINIC OVULATION PREDICTION TEST Vanguard Biomedical Corp. CEP Class I 1991-03-21
K910349 IMMUNOCORP COATED TUBE IRMA HCG Immunocorp JHI Class II 1991-03-21
K905405 CHEMTRAK ACCUMETER CHOLESTEROL TEST Chemtrak, Inc. CHH Class I 1991-03-19
K910717 PANTEX IRMA LH 1251 KIT Pantex, Div. Bio-Analysis, Inc. CEP Class I 1991-03-19
K903034 RENALYZER PRX 90 Swedish Trade Council USA CGL Class II 1991-03-13
K910638 SYSTEMATE TRIGLYCERIIDES (EPOS APPLICATION) #65477 Em Diagnostic Systems, Inc. CDT Class I 1991-03-11
K905227 GLUCOSE (HK) REAGENT, UNIVERSAL Enzyme Technology, Inc. CFR Class II 1991-03-11
K904031 CHEMA CHOL CHOLESTEROL SYSTEM Texas Intl. Laboratories, Inc. CHH Class I 1991-03-11
K905683 BIOTROL LACTATE DEHYDROGENASE (L-P) Biotrol, USA, Inc. CFJ Class II 1991-03-11
K910147 CREATININE REAGENT(CREAT), CAT.# RE0015/MODIFIED Olympus Corp. CGX Class II 1991-03-11
K910343 CIBA CORNING ACS VITAMIN B12 IMMUNOASSAY Ciba Corning Diagnostics Corp. CDD Class II 1991-03-06
K910554 CLINAK(TM) ISE SUBSYSTEM Baxter Healthcare Corp JGS Class II 1991-03-06
K905648 CRP LIPID REAGENT TEST PACK Cirrus Diagnostics, Inc. CHH Class I 1991-03-06
K905264 STAT PROFILE 8 ANALYZER,CALIBRATORS AND MATERIALS Nova Biomedical Corp. JGS Class II 1991-03-05
K910108 GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED Gds Diagnostics JIN Class I 1991-03-04
K910296 PHOSPHORUS (INORGANIC) TEST SYSTEM Biochemical Trade, Inc. CEO Class I 1991-02-27
K910222 COBAS ALPHA Roche Diagnostic Systems, Inc. JJG Class I 1991-02-27
K910133 CHLORIDE REAGENT (C1), CATALOG NO. DR0011/MODIFIED Olympus Corp. CHJ Class II 1991-02-27
K910160 ELECTROPHORESIS CONTROL Seradyn, Inc. JIT Class II 1991-02-27
K905771 COULTER DART AST (GOT) REAGENT Coulter Electronics, Inc. CIT Class II 1991-02-26
K910420 BIOCLONE'S ELEGANCE HCG ELISA KIT Bioclone Australia Pty , Ltd. JHI Class II 1991-02-26
K905776 ALBUMIN REAGENT SET Biochemical Trade, Inc. CJW Class II 1991-02-26
K905618 GGT REAGENT Amresco, Inc. JPZ Class I 1991-02-26
K905820 ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1(LD1) VERI E.I. Dupont DE Nemours & Co., Inc. JIS Class II 1991-02-26
K905145 ECLIPSE ICA CHOLESTEROL Biotope, Inc. CHH Class I 1991-02-26
K910240 CHOLESTAT (TM) WHOLE BLOOD CHOLESTEROL TEST Crystal Diagnostics, Inc. CHH Class I 1991-02-26
K910302 ECLIPSE ICA ANALYZER Biotope, Inc. JJQ Class I 1991-02-22
K905623 CK-MB IMMUNOASSAY CONTROL Seradyn, Inc. JJT Class I 1991-02-22

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