ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

KALLESTAD RSV MICROPLATE EIA

FDA 510(k)

FDA Class 1 ·Microbiology

ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ACCESS CHLAMYDIA ASSAY

FDA 510(k)

FDA Class 1 ·Microbiology

ACCESS MYOGLOBIN REAGENTS

FDA 510(k)

FDA Class 2 ·Immunology

LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ACCESS ALLERGEN DOG EPITHELIM

FDA 510(k)

FDA Class 2 ·Immunology

ACCESS TOTAL BHCG ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK

FDA 510(k)

FDA Class 2 ·Hematology

KALESTAD ANA MICROPLATE EIA

FDA 510(k)

FDA Class 2 ·Immunology

ACCESS TOTAL T3 ASSAY (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACCESS VITAMIN B12 ASSAY (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VARIANT II TURBO HbA1c Kit - 2.0

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

D-10 Hemoglobin A1c Program

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200

FDA 510(k)

FDA Class 2 ·Immunology

VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730

FDA 510(k)

FDA Class 2 ·Hematology

ACCESS PROGESTERONE ASSAY

FDA 510(k)

FDA Class 1 ·Clinical Chemistry