BOVO MOISTURE GUARD

FDA 510(k)

FDA Class 1 ·Dental

Infinity Pro, Logic, Quality, Sprint

FDA 510(k)

FDA Class 1 ·Dental

OPTICAL FRAMES AND/OR SUNGLASSES

FDA 510(k)

FDA Class 1 ·Ophthalmic

Infinity / Infinity Cross Flex Dental Systems

FDA 510(k)

FDA Class 1 ·Dental

ADD'L CLAIMED INTENDED USE FOR IDEIA(TM) CHLAMYDIA

FDA 510(k)

FDA Class 1 ·Microbiology

LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

LD-1 ISOENZYME CONTROL (HUMAN) LEVEL 1 & 2

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

SERUM VOLATILES CONTROL - LEVELS 1 AND 2

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\S

FDA 510(k)

FDA Class 1 ·Clinical Toxicology

CKMB CONTROL - LEVEL 1,2,3

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MULTI LEVEL CONTROL FOR CKMB ISOENSYME IN SYRUM

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL

FDA 510(k)

FDA Class 1 ·Clinical Toxicology

WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2

FDA 510(k)

FDA Class 1 ·Clinical Toxicology

LD-1 CONTROL-LEVEL 1 & 2

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC LEVEL

FDA 510(k)

FDA Class 1 ·Clinical Toxicology

WHOLE BLOOD VOLATILES CONTROL, LEVELS 1 AND 2

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

CKMB ISOENZYME CONTROL(HUMAN) LEVEL 1,2,& 3

FDA 510(k)

FDA Class 1 ·Clinical Chemistry