QBC CENTRIFUGAL HEMATOLOGY CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

ADVIA CENTAUR HOMOCYSTEINE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVIA RETIC PLUS

FDA 510(k)

FDA Class 2 ·Hematology

CODETRON TRANSCUTANEOUS ELECTRICAL NERVE STIMULA.

FDA 510(k)

FDA Class 2 ·Neurology

CBC-SF

FDA 510(k)

FDA Class 2 ·Hematology

COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

ADVIA 60 HEMATOLOGY ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

AVANTE Z; PELLET, PRESSABLE STAIN, ADD-ON PORCELAIN, PORCELAIN

FDA 510(k)

FDA Class 2 ·Dental

BRUKER R-28,HEAD AND CHEST ANGIOGRAPHY IMAGING ADD

FDA 510(k)

FDA Class 2 ·Radiology

ADD MIX ALLERGEN PANEL MOD ALASTAT(R) ALLERGEN IGE

FDA 510(k)

FDA Class 2 ·Immunology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

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

SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE

FDA 510(k)

FDA Class 2 ·Radiology

HEMOD CONCE OF VAR FORMU & LIPUID HEMOD CONCE ADD

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

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

Access Vitamin B12

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

'NO-BOIL' VITAMIN B12 KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LIAISON Vitamin B12

FDA 510(k)

FDA Class 2 ·Clinical Chemistry