Wiener Laboratories Saic - 24 FDA 510(k) Chemistry Devices (Since 2001)

WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254

K023889 · MIU Enzyme Linked Immunosorbent Assay, T. Cruzi · Microbiology

Feb 2004 447d

WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006

K024305 · JIX Calibrator, Multi-analyte Mixture · Chemistry

Mar 2003 84d

WIENER LAB COLINESTERASA AA

K023992 · DIH Colorimetry, Cholinesterase · Chemistry

Feb 2003 72d

WIENER LAB. BILIRUBINA DIRECT AA

K024116 · CIG Diazo Colorimetry, Bilirubin · Chemistry

Feb 2003 61d

WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354

K023744 · JHW U.v. Method, Cpk Isoenzymes · Chemistry

Jan 2003 57d

WIENER LAB AMILASA 405 AA LIQUIDA

K023549 · JFJ Catalytic Methods, Amylase · Chemistry

Dec 2002 48d

WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA

K023550 · KNK Acid, Uric, Uricase (colorimetric) · Chemistry

Dec 2002 48d

WIENER LAB GOT (AST) UV AA LIQUIDA

K023551 · CIT Nadh Oxidation/nad Reduction, Ast/sgot · Chemistry

Dec 2002 48d

WIENER LAB. BILIRRUBINA TOTAL AA

K022962 · CIG Diazo Colorimetry, Bilirubin · Chemistry

Nov 2002 56d

WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER LAB.CA-COLOR ARSENAZO III AA, MODEL 8 X 20 5

K021334 · CJY Azo Dye, Calcium · Chemistry

Sep 2002 137d

WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV AA, WIENER LAB.NAC UV AA LIQUIDA

K021332 · CGS Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes · Chemistry

Jul 2002 68d

WIENER LAB. ALP 405

K013983 · CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes · Chemistry

Jan 2002 56d

Wiener Laboratories Saic - FDA 510(k) Cleared Devices