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

SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3

FDA 510(k)

FDA Class 1 ·Clinical Toxicology

CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

CKMB ISOENZYME CONTROL-LEVEL 1,2.3

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3

FDA 510(k)

FDA Class 1 ·Clinical Toxicology

SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Stylet, Tracheal Tube

FDA classification

FDA Class 1 ·Stylet, Tracheal Tube

ENTERIC PATHOGEN TRANSPORT (EPT) (E1020,E1000)

FDA 510(k)

FDA Class 1 ·Microbiology

DENTAL OPERATIVE UNIT ACCESORIES

FDA 510(k)

FDA Class 1 ·Dental

SKED FLOTATION SYSTEM

FDA 510(k)

FDA Class 1 ·General Hospital

A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43

FDA 510(k)

FDA Class 1 ·Dental

KHBS (KRISHNAMURTHY HEPATO-BILIARY SOFTWARE), MODEL VERSION 1.5

FDA 510(k)

FDA Class 1 ·Radiology

3M ORTHOPEDIC CASTING TAPE

FDA 510(k)

FDA Class 1 ·Physical Medicine