meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
55
Latest Decision
1987-10-23

Clearances · page 81 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K873127 CHLORIDE REAGENT KIT A-Kem, Inc. JFS Class II 1987-10-23
K873131 CREATININE REAGENT KIT A-Kem, Inc. CGX Class II 1987-10-23
K873431 PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH Serono Diagnostics, Inc. JLS Class I 1987-10-20
K873399 TITAN GEL CPK REP SYSTEM Helena Laboratories JHX Class II 1987-10-20
K872730 RESULT PLUS/HCG PREGNANCY TEST Ortho Diagnostic Systems, Inc. JHI Class II 1987-10-20
K870516 ALBUMIN SCREEN TEST Sclavo, Inc. JIQ Class I 1987-10-20
K873725 MULTICHEM CREATININE REAGENT S0917 Simmler, Inc. CGX Class II 1987-10-20
K873386 TITAN GEL LDH REP SYSTEM Helena Laboratories CFE Class II 1987-10-20
K873250 ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL Roche Diagnostic Systems, Inc. CIJ Class II 1987-10-20
K873051 STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY American Dade CGJ Class I 1987-10-20
K873572 IL 35260, IL TEST AMYLASE REAGENT Instrumentation Laboratory CO CIJ Class II 1987-10-20
K873642 OSMOMETER MODEL 110 Advanced Instruments, Inc. JJM Class I 1987-10-20
K873074 SODIUM AND POTASSIUM BY ION SELECTIVE American Monitor Corp. JGS Class II 1987-10-20
K873342 BILE ACIDS CONTROLS Sigma Diagnostics, Inc. JJX Class I 1987-10-20
K873611 A-QC CLINICAL CHEMISTRY CONTROL Arden Medical Systems, Inc. JJY Class I 1987-10-20
K872505 DIASCAN* BLOOD GLUCOSE SELF-MONITORING TEST STRIPS Home Diagnostics, Inc. CGA Class II 1987-10-20
K873749 CIBA CORNING/SHIMADZU MODEL 570 CHEM. ANALYZER Ciba Corning Diagnostics Corp. JJE Class I 1987-10-19
K873363 URIC ACID PAP Boehringer Mannheim Corp. KNK Class I 1987-10-19
K873617 GEMSTAR II SYSTEM Electro-Nucleonics Laboratories, Inc. JJE Class I 1987-10-19
K873863 APOLIPOPROTEIN A1 Unipath , Ltd. MSJ Class I 1987-10-13
K873864 APOLIPOPROTEIN B Unipath , Ltd. MSJ Class I 1987-10-13
K873355 MEDIX BIOTECH PROLACTIN ENZYME IMMUNO. TEST KIT Medix Biotech, Inc. CFT Class I 1987-10-09
K873416 MULTI-ACCESS REAGENT DISPENSER Electro-Nucleonics Laboratories, Inc. JQW Class I 1987-10-09
K873761 MULTICHEM ALKALINE PHOSPHATASE (S0903) Simmler, Inc. CJE Class II 1987-10-07
K873668 MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT Medix Biotech, Inc. CEP Class I 1987-10-07
K873524 AFFINITY HCG IMMUNIT (POLYCLONAL) Bd Becton Dickinson Vacutainer Systems Preanalytic JHI Class II 1987-10-06
K873133 BNP-AMYLASE TEST Sclavo, Inc. JFJ Class II 1987-10-06
K873335 WAKO(TM) AUTOKIT UREA N Wako Chemicals USA, Inc. CDQ Class II 1987-10-02
K873547 TITAN GEL HDL CHOLESTEROL KIT Helena Laboratories LBT Class I 1987-10-02
K873333 WAKO(TM) AUTOKIT ALP Wako Chemicals USA, Inc. CJE Class II 1987-10-02
K873697 MULTICHEM CALCIUM S0910 Simmler, Inc. CIC Class II 1987-10-02
K873551 CONJUGATED BILIRUBIN (CBIL) ITEM NO. 67684/95 Em Diagnostic Systems, Inc. CIG Class II 1987-10-02
K873365 CREATININE REAGENT Sigma Diagnostics, Inc. CGX Class II 1987-10-02
K873334 WAKO(TM) AUTOKIT CALCIUM Wako Chemicals USA, Inc. CIC Class II 1987-10-02
K871241 ANSWER OVULATION TEST KIT Armkel, LLC CEP Class I 1987-10-02
K873303 BINAX L.S. TSH IRMA TEST KIT Binax, Inc. JLW Class II 1987-10-02
K873678 SPECTROPHOTOMETER (MICROASSAY PLATE READERS) Slt Labinstruments, Inc. JJQ Class I 1987-09-29
K871759 G-GT STANDARD CALIBRATOR Wako Chemicals USA, Inc. JIT Class II 1987-09-29
K873186 LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA Serono Diagnostics, Inc. CEP Class I 1987-09-29
K873171 STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY American Dade JHX Class II 1987-09-29
K873681 ALKALINE PHOSPHATASE (ALK P) TESTPACK #67690/95 Em Diagnostic Systems, Inc. CJE Class II 1987-09-29
K873638 MICRO-CHEM ANALYZER Ocean Scientific, Inc. JJQ Class I 1987-09-29
K873400 PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA Serono Diagnostics, Inc. CFT Class I 1987-09-25
K871970 DOUBLE ANTIBODY ULTRA-PTH #KPTD1 AND KPTD2 Diagnostic Products Corp. CEW Class II 1987-09-25
K872794 MEDIX BIOTECH APOLIPOPROTEIN A-I TEST KIT Medix Biotech, Inc. MSJ Class I 1987-09-23
K873603 FINNIGAN MAT INCOS 50 Finnigan Corp. JJO Class I 1987-09-22
K873583 AUTO-EIA Labsystems, Inc. JJQ Class I 1987-09-22
K873553 WAKO(TM) PRETEST 8A Wako Chemicals USA, Inc. JJB Class I 1987-09-22
K873450 TRI-LEVEL LIGAND CONTROL Ciba Corning Diagnostics Corp. JJX Class I 1987-09-21
K872862 PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS Serono Diagnostics, Inc. CFT Class I 1987-09-18
K872051 CALCIUM CALIBRATOR Wako Chemicals USA, Inc. JIS Class II 1987-09-18
K872749 SPECTROPHOTOMETERS MODELS:ABC+,ABC,S 500, S 1000 Secomam Co. JJQ Class I 1987-09-16
K873134 UNIFAST CK-MB Sclavo, Inc. CGS Class II 1987-09-16
K872041 COULTER DART CK-MB ISOENZYME REAGENT SYSTEM Coulter Electronics, Inc. JHT Class II 1987-09-16
K872891 LACTATE DEHYDROGENASE ISOENZYME 1 Data Medical Associates, Inc. CEX Class II 1987-09-16
K871586 GLUCOCHEK S.C. WITH AUDIO OPTION Larken Industries, Inc. CGA Class II 1987-09-16
K873105 REFLO-CHEX, A CHOLESTEROL REFERENCE CONTROL Streck Laboratories, Inc. JJX Class I 1987-09-16
K873424 EASY-TEST CONJUGATED BILIRUBIN (CBIL) #16690 Em Diagnostic Systems, Inc. CIG Class II 1987-09-14
K873052 STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY American Dade CEP Class I 1987-09-14
K872646 VIRON(TM) bioMerieux, Inc. JJT Class I 1987-09-14
K873033 HCG SEROZYME IMMUNOENZYM ASSAY KIT/MAG SOLID PHASE Serono Diagnostics, Inc. JHI Class II 1987-09-14
K873138 MICRO-READER II Hyperion, Inc. JJQ Class I 1987-09-14
K870268 DIAGNOSTIC KIT FREE T3 AND FREE T4 Sclavo, Inc. CEC Class II 1987-09-14
K873345 'MICROLYTE 4/5' Kone Instruments, Inc. JFP Class II 1987-09-11
K873358 GEMENI URIC ACID U.V. Electro-Nucleonics Laboratories, Inc. CDO Class I 1987-09-11
K872073 BIO-INTERFERENCE BLANKING MATERIAL, AM CAT. #2052 American Monitor Corp. JIT Class II 1987-09-11
K873352 RAPID ELECTROPHORESIS SYSTEM (REP) Helena Laboratories JJN Class I 1987-09-08
K873160 BIOTROL TRIGLYCERIDES ENZYMATIQUE COLOR Biotrol, USA, Inc. CDT Class I 1987-09-08
K873408 MODEL 690 SPECTROPHOTOMETER Abbott Diagnostics JJQ Class I 1987-09-08
K872302 MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER Ciba Corning Diagnostics Corp. JJE Class I 1987-09-08
K873378 GAMMA GLUTAMYLTRANSFERASE Catachem, Inc. JQB Class I 1987-09-08
K872831 BIOTROL ALPHA AMYLASE Biotrol, USA, Inc. CIJ Class II 1987-09-04
K873135 UNIFAST GAMMA-GT Sclavo, Inc. JQB Class I 1987-09-04
K872803 CYBERFLUOR 615 IMMUNOANALYZER Cyberfluor, Inc. KHO Class I 1987-09-02
K872390 ALLEGRO(TM) HUMAN CHORIONIC GONADOTROPIN IM SYSTEM Nichols Institute Diagnostics JHI Class II 1987-09-02
K872789 PARAMAX URINE/CSF CALIBRATOR American Dade JIX Class II 1987-09-02
K873310 ABBOTT SPECTRUM(R) LIQUID CREATININE REAGENT Abbott Laboratories CGX Class II 1987-09-02
K871903 QUICK QUALITATIVE CALCIUM TEST (QUICK-CAL) Creative Scientific Technology, Inc. JFN Class II 1987-09-02
K873116 MULTI ANALYTE MIXTURES, CALIBRATORS Biotrol, USA, Inc. JIX Class II 1987-09-02
K873180 BIOTROL MAGNESIUM CALMAGITE Biotrol, USA, Inc. JGJ Class I 1987-09-02
K873118 BIOTROL REFERENCE Biotrol, USA, Inc. JIX Class II 1987-09-02
K873117 BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT Biotrol, USA, Inc. CGA Class II 1987-08-31
K864849 ANTEK 703C CHEMILUMINESCENT NITROGEN ANALYZER Antek Instruments, Inc. JJE Class I 1987-08-28
K873049 TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL Boehringer Mannheim Corp. CDT Class I 1987-08-28
K872310 CURAD MEDICATED PLASTIC STRIPS The Kendal Co. CGX Class II 1987-08-28
K871601 ADVANCE* PREGNANCY TEST ACP 2 PREGNANCY TEST Advanced Care Products LCX Class II 1987-08-26
K872785 BIOTROL-33 PLUS ASSAYED CHEMISTRY CONTROL SERUM Biotrol, USA, Inc. JJY Class I 1987-08-26
K872296 BILE ACIDS REAGENT Sigma Diagnostics, Inc. KWW Class II 1987-08-26
K872777 BIOTROL-33 PLUS PATHOLOGIQUE ASSAYED CHEM. CONTROL Biotrol, USA, Inc. JJY Class I 1987-08-26
K872131 TANDEMR M-PAK LH IMMUNOENZYMETRIC ASSAY Hybritech, Inc. CEP Class I 1987-08-25
K873120 ABBOTT A-GENT IRON REAGENT KIT Abbott Laboratories CFM Class I 1987-08-25
K872888 CIBA CORNING 288 PH/BLOOD GAS SYSTEM Ciba Corning Diagnostics Corp. JQY Class I 1987-08-25
K871499 PROTOFLUOR Z Helena Laboratories JKJ Class I 1987-08-25
K870367 CHLORIDE REAGENT - THIOCYANATE METHOD Trace Scientific , Ltd. CHJ Class II 1987-08-21
K872512 EMDS TOTAL BILIRUBIN (TBIL) TESTPACKS, #67675/95 Em Diagnostic Systems, Inc. CIG Class II 1987-08-21
K872487 VISION(R) TOTAL BILIRUBIN Abbott Laboratories CIG Class II 1987-08-21
K872930 BIOTROL CHOLESTEROL ENZYMATIQUE COLOR Biotrol, USA, Inc. CHH Class I 1987-08-21
K872451 BILE ACIDS CALIBRATOR Sigma Diagnostics, Inc. JIT Class II 1987-08-21
K872430 ISO-DATA 500 SERIES GAMMA COUNTER Iso-Data, Inc. JJJ Class I 1987-08-21
K872513 EASY-TEST TOTAL BILIRUBIN (TBIL) ITEM NO. 16604 Em Diagnostic Systems, Inc. CIG Class II 1987-08-21

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