CREATINE KINASE FOR CONTINUOUS FLOW INSTRUMENTS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

QUANTECH CK-MB ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·FREEZOR CARDIAC CRYOABLATION CATHETERS, FREEZOR XTRA AND FREEZOR MAX SURGICAL CRYOABLATION CATHETERS & CCT. CRYOCONSOLE

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·FREEZOR CARDIAC CRYOABLATION CATHETER/ FREEZOR XTRA & MAX SURGICAL CRYOABLATION & CCT.2 CRYOCONSOLE SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·FREEZOR CARDIAC CRYOABLATION CATHETERS AND FREEZOR XTRA SURGICAL CRYOABLATION CATHETERS & CCT.2 CRYOCONSOLE SYSTEM

Freedom pendant system

Basic UDI-DI

EU MDR · Eu Md Class 1 ·IHBO B.V.·4 devices

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·FREEZOR CARDIAC CRYOABLATION CATHETER/FREEZOR XTRA & FREEZOR MAX SURGICAL CRYOABLATION DEVICES & CCT.2 CRYOCONSOLE

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·FREEZOR CARDIAC CRYOABLATION CATHETERS/FREEZOR XTRA & FREEZOR MAX SURGICAL CRYOABLATION DEVICES& CCT.2 CRYOCONSOLE SYSTE

IMMUNOSCAN RA ANTI-CCP TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology