ARCHITECT TOTAL P-HCG MASTERCHECK, LIST NO. 6C21-05

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

FLUOROMATIC PHENOLBARBITAL FIA

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

VARIANT II HEMOGLOBIN A1C PROGRAM

FDA 510(k)

FDA Class 2 ·Hematology

MICROMAT MODEL 415 - BICHROMATIC FILTER PHOTOMETER

FDA 510(k)

FDA Class 2 ·Hematology

LYPHOCHEK BENZO/TCA CONTROL SERUM, LEVELS 1 AND 2

FDA 510(k)

FDA Class 1 ·Clinical Toxicology

ABBOTT TUMOR MARKER-MCC (LYOPHILIZED), MODEL 6E21-10

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ARCHITECT LH MASTERCHECK, MODEL NUMBER 6C25-05

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

RADIAS ANA SCREEN ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

PLATELIA ASPERGILLUS EIA MODEL 62793

FDA 510(k)

FDA Class 1 ·Microbiology

LYPHOCHEK QUANTITATIVE URINE CONTROL ABNORMAL (2)

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS

FDA 510(k)

FDA Class 2 ·Microbiology

LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783

FDA 510(k)

FDA Class 2 ·Hematology

LYPHOCHEK(R) IMMUNOASSAY CONTR SERUM (HUMAN) 1,2,3

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

QUANTAPHASE II B12/FOLATE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ARCHITECT FERRITIN MASTERCHECK, MODEL NUMBER 6C11-05

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALOG #118

FDA 510(k)

FDA Class 2 ·Immunology

LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116

FDA 510(k)

FDA Class 2 ·Immunology

LYPHOCHEK WHOLE BLOOD CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438; LEVEL S2E, MODEL 439

FDA 510(k)

FDA Class 1 ·Clinical Toxicology

TEST, RIA, TSH QUANTIMUNE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry