meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
58
Latest Decision
1997-12-05

Clearances · page 42 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K974047 ACCUWELL PHENYLALANINE ASSAY Neometrics, Inc. JNB Class II 1997-12-05
K973742 SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM Sendx Medical, Inc. CGZ Class II 1997-12-03
K973841 QUICKVUE ONE-STEP HCG-COMBO Quidel Corp. JHI Class II 1997-12-01
K973928 BECKMAN URINE PROTEIN CALIBRATOR (UCAL) Beckman Instruments, Inc. JIX Class II 1997-12-01
K973858 CARDS Q.S. HCG SERUM/URINE;CONCISE PERFORMANCE PLUS HCG-COMBO Quidel Corp. JHI Class II 1997-11-26
K974108 SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE) Quidel Corp. JJX Class I 1997-11-26
K974103 ABBOTT AXSYM TROPONIN-I Abbott Laboratories MMI Class II 1997-11-25
K973931 UREA-SL ASSAY CATALOGUE NUMBER 239-10, 239-30 Diagnostic Chemicals , Ltd. CDQ Class II 1997-11-24
K973901 17 B-ESTRADIOL (ELISA) Kmi Diagnostics, Inc. CHP Class I 1997-11-24
K973369 ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM) Roche Diagnostic Systems, Inc. LBR Class I 1997-11-21
K973276 AUTODELFIA NEONATAL HTSH L KIT (B077-112) Eg &G Wallac JLW Class II 1997-11-20
K973897 DHEA-S Kmi Diagnostics, Inc. JKC Class I 1997-11-13
K973898 PROGESTERONE ELISA Kmi Diagnostics, Inc. JLS Class I 1997-11-13
K974001 ASPARTATE AMINOTRANSFERASE-SL ASSAY, CATALOGUE NUMBER 319-10, 319-30 Diagnostic Chemicals , Ltd. CIT Class II 1997-11-13
K973702 ELECSYS VITAMIN B12 ASSAY Boehringer Mannheim Corp. CDD Class II 1997-11-13
K973674 ELECSYS FOLATE Boehringer Mannheim Corp. CDD Class II 1997-11-12
K974075 ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER Beckman Instruments, Inc. MMI Class II 1997-11-10
K973974 DADE TRU-LIQUID CARDIAC CONTROL Dade Intl., Inc. JJT Class I 1997-11-06
K973879 OSOM CARD HCG-URINE TEST Wyntek Diagnostics, Inc. JHI Class II 1997-11-04
K974000 Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30 Diagnostic Chemicals , Ltd. JQB Class I 1997-11-04
K973933 SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30 Diagnostic Chemicals , Ltd. JIY Class I 1997-11-04
K973743 ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER Beckman Instruments, Inc. CHP Class I 1997-10-31
K973570 QUICK CARD HCG ONE STEP PREGNANCY TEST Phamatech LCX Class II 1997-10-31
K973514 ACTIVE INTACT PTH Diagnostic Systems Laboratories, Inc. CEW Class II 1997-10-31
K973966 ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER Beckman Instruments, Inc. CDP Class II 1997-10-31
K973140 DUET GLUCOSE CONTROL MONITORING SYSTEM Lxn Corp. CGA Class II 1997-10-31
K973894 IMMUSURE Quantimetrix Corp. JJY Class I 1997-10-29
K973345 MATRIX PLUS MULTI-CALIBRATOR KIT Verichem Laboratories, Inc. JIX Class II 1997-10-29
K973832 OPUS HLH CONTROLS Behring Diagnostics, Inc. JJX Class I 1997-10-27
K973310 TBD* ONE-STEP OVULATION PREDICTOR TEST Armkel, LLC CEP Class I 1997-10-27
K972015 HYDRAGEL 7,15,30, CHOL-HDL KIT Morax LBT Class I 1997-10-27
K973352 BRAND NAME *1-STEP PREGNANCY Armkel, LLC LCX Class II 1997-10-27
K972274 SPIFE Helena Laboratories CEF Class I 1997-10-27
K973588 LIQUID ALKALINE PHOSHATASE REAGENT SET Pointe Scientific, Inc., CJE Class II 1997-10-22
K973208 FIRST SIGN Texas Immunology, Inc. LCX Class II 1997-10-20
K973668 CARDIAC TROPONIN-I (TROP) CALIBRATOR Dade Intl., Inc. JIT Class II 1997-10-20
K973142 DBEST REAGENT STRIP FOR URINALYSIS Ameritek, Inc. JIL Class II 1997-10-20
K973650 TROPONIN (TROP) METHOD Dade Chemistry Systems, Inc. MMI Class II 1997-10-20
K973292 I-STAT SYSTEM I-Stat Corp. CGL Class II 1997-10-20
K973791 ABC CALIBRATION VERIFIERS Sc Calibrators & Controls, LLC JJY Class I 1997-10-14
K973790 ABC LINEARITY VERIFIERS Sc Calibrators & Controls, LLC JJY Class I 1997-10-14
K973157 LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET Pointe Scientific, Inc., JQB Class I 1997-10-10
K972876 GLUCOTREND BASIC SYSTEM Boehringer Mannheim Corp. LFR Class II 1997-10-09
K973177 MAGO AUTOMATED EIA PROCESSOR Diamedix Corp. JJF Class I 1997-10-09
K973589 LIQUID LDH-L REAGENT SET Pointe Scientific, Inc., CFJ Class II 1997-10-08
K972986 ACCURUN 140 RUBELLA IGG POSITIVE CONTROL Boston Biomedica, Inc. MJX Class I 1997-10-08
K973629 PRECINORM RF, PRECIPATH RF Boehringer Mannheim Corp. JJY Class I 1997-10-07
K973358 MYOGLOBIN CONTROL SET Boehringer Mannheim Corp. JJX Class I 1997-10-06
K973126 TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN, TRIAGE TROPONIN-I AND CK-MB, TRIAGE TROPONIN-I Biosite Incorporated JHX Class II 1997-10-06
K972974 ACCUWELL T4-EIA Neometrics, Inc. KLI Class II 1997-10-06
K973074 2487 DUAL WAVELENGTH ABSORBANCE DETECTOR Waters Corporation KZR Class I 1997-10-06
K973367 ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM Radiometer America, Inc. CHL Class II 1997-10-06
K973316 REP SPE VIS-60/40 KIT Helena Laboratories CEF Class I 1997-10-01
K973451 MAS LIQUID URINALYSIS CONTROL LEVEL 1, LEVEL 2 AND LEVEL 3 Medical Analysis Systems, Inc. JJW Class I 1997-09-29
K973099 PROSTATE SPECIFIC ANTIGEN CONTROL Dade Chemistry Systems, Inc. JJX Class I 1997-09-29
K973100 PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR Dade Chemistry Systems, Inc. JIT Class II 1997-09-29
K973469 QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 AND 2, CONFORMANCEMCCLIQUICHEM UNASSAYED LIQUID CHEMISTRY CONTROL LEVELS Consolidated Technologies, Inc. JJY Class I 1997-09-25
K973109 SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT Synermed, Inc. CIG Class II 1997-09-25
K972761 SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY Sealite Sciences, Inc. CFL Class I 1997-09-25
K973055 WAKO CH50 LINEARITY SET Wako Chemicals USA, Inc. JIW Class II 1997-09-25
K973517 VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS Johnson & Johnson Clinical Diagnostics, Inc. JJY Class I 1997-09-25
K972853 CHOLESTEROL RAPID LIQUID REAGENT Reagents Applications, Inc. CHH Class I 1997-09-24
K972580 DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM Bayer Corp. JMM Class I 1997-09-22
K972743 SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENT Sigma Diagnostics, Inc. CGX Class II 1997-09-22
K971145 GLUCOSITE TEST SYSTEM Gds Technology, LLC CGA Class II 1997-09-17
K973072 WAKO NEFA LINEARITY SET Wako Chemicals USA, Inc. JJX Class I 1997-09-12
K972666 TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY Hybritech, Inc. CIN Class II 1997-09-11
K972706 CLINITEK MICROALBUMIN REAGENT STRIPS Bayer Corp. CJG Class II 1997-09-09
K972733 AVL OMNI ANALYZER Avl Scientific Corp. CGA Class II 1997-09-09
K973030 VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300) Johnson & Johnson Clinical Diagnostics, Inc. JJY Class I 1997-09-04
K972720 FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300) Monobind CGJ Class I 1997-09-02
K971458 ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT Diagnostic Specialties JIQ Class I 1997-09-02
K972742 QUICKVUE ONE-STEP HCG-URINE Quidel Corp. JHI Class II 1997-08-29
K972586 AIA-PACK TSH 3RD-GEN ASSAY Tosoh Medics, Inc. JLW Class II 1997-08-29
K972976 CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL More Diagnostics JJT Class I 1997-08-29
K972748 CARDS Q.S. HCG-URINE; AND CONCISE PERFORMANCE PLUS HCG-URINE Quidel Corp. JHI Class II 1997-08-29
K972606 PREGNACOL PREGNANCY TEST Immunostics Inc., JHJ Class II 1997-08-29
K972868 TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL Bionostics, Inc. JJY Class I 1997-08-28
K972409 AG CHEMISTRY ANALYZER SYSTEM Landmark Scientific, Inc. JJG Class I 1997-08-28
K972141 THE YELLOW IRIS URINALYSIS WORKSTATION Intl. Remote Imaging Systems KQO Class I 1997-08-25
K972673 AVL 9181 ELECTROLYTE ANALYZER Avl Scientific Corp. JFP Class II 1997-08-20
K972861 IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3) Instrumentation Laboratory CO JJS Class I 1997-08-19
K972710 QUANTIFY(901) Hematronix, Inc. JJW Class I 1997-08-15
K972363 IL TEST IRON Instrumentation Laboratory CO JIY Class I 1997-08-15
K972782 DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY Dade Intl., Inc. JHX Class II 1997-08-15
K972182 ABBOTT STREP A CONTROLS Abbott Diagnostics MJZ Class I 1997-08-13
K972250 ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS Roche Diagnostic Systems, Inc. JFJ Class II 1997-08-12
K972129 CHLAMYDIATROL AG Blackhawk Biosystems, Inc. MJZ Class I 1997-08-12
K971657 ACCURUN 121 HAV IGM POSITIVE CONTROL Boston Biomedica, Inc. JJY Class I 1997-08-12
K972048 ACCURUN 117 HBEAG POSITIVE CONTROL Boston Biomedica, Inc. JJY Class I 1997-08-12
K972235 PRECICONTROL TUMOR MARKER 1 AND 2 Boehringer Mannheim Corp. JJY Class I 1997-08-12
K972337 DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA Diagnostic Chemicals , Ltd. JIR Class I 1997-08-08
K971812 PRECISION QID BLOOD GLUCOSE TEST STRIP, PRECISION G BLOOD GLUCOSE TEST STRIP Medisense, Inc. CGA Class II 1997-08-08
K972716 SYNERMED TOTAL BILIRUBIN REAGENT KIT Synermed, Inc. CIG Class II 1997-08-07
K972307 ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL Boston Biomedica, Inc. JJY Class I 1997-08-07
K971406 ACCURUN 120 HAV IGG POSITIVE CONTROL Boston Biomedica, Inc. JJY Class I 1997-08-07
K972721 ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P Roche Diagnostic Systems, Inc. JJX Class I 1997-08-06
K972167 PLASMA CATECHOLAMINE KIT Bioanalytical Systems, Inc. CHQ Class I 1997-08-04
K972608 RANDOX ASSAYED SPECIFIC PROTEIN CONTROL Randox Laboratories, Ltd. JJY Class I 1997-08-04
K970664 GLUCOSE REAGENT Derma Media Lab., Inc. CFR Class II 1997-08-01

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