Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CHANGES TO ACS(R) SLALOM ADD 1.5 MM BALLOON SIZE

ADDED USE CLAIM FOR DUPONT ACA BETA-2-MICROGLOBULIN TEST PACK

FDA 510(k)

FDA Class 2 ·Immunology

DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOB

FDA 510(k)

FDA Class 2 ·Immunology

VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AIA-PACK B12 ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

K-ASSAY HAPTOGLOBIN

FDA 510(k)

FDA Class 2 ·Immunology

Access Vitamin B12

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

'NO-BOIL' VITAMIN B12 KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SPQ TEST SYSTEM FOR HAPTOGLOBIN

FDA 510(k)

FDA Class 2 ·Immunology

LIAISON Vitamin B12

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HAPTOGLOBIN NEPHELOMETRIC ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

VITAMIN B12 - NO-BOIL KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COMBOSTAT - NO-BOIL KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT

FDA 510(k)

FDA Class 2 ·Immunology

IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT

FDA 510(k)

FDA Class 2 ·Immunology

DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VISTA B12 ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SPQ(TM) ANTIBODY REAGENT SET II FOR HPT

FDA 510(k)

FDA Class 2 ·Immunology

AXIS-SHIELD ACVTIVE-B12

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry