CIBA CORNING ACS CKMB IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EMBRIA-CK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CREATINE KINASE REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SIGMA PROCEDURE NO. 745 - EP.REAGENT SY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CREATINE KINASE-MB KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IMACK-MB, CATALOGS 602-1, 602-1/125, 602-1/225

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IMX(R) STAT CK-MB

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SPIFE CK KIT, MODEL 3332, 3333

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IMPRES-MB REAGENT A AND REAGENT B

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LERADO, POWER WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LEOCOR PICO-ST

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LEOCOR PERCUTANEOUS ANGIOPLASTY CATHETER (PTCA), MODEL 5S, LEOCOR CORFLO MODEL 7.5PT COATED PTCA, AND CORFLO HEMO PUMP

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LEOCOR CORFLO(TM) MODEL 7.5PT & PICO-ST COATED CAT

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LEOCOR CORFLO(TM) MODEL 7.5PT PTCA CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LEOCOR SABLE(TM) PTCA CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LEOCOR CORFLO(TM) MODEL 7.5PT & PICO-ST COATED CAT

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LEOCOR,INC. PICOCATH CATHETER 2,2.5,3,3.5, BALLOON

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LEOCOR PICO RUNNER CATHETER