DRUG TESTING ASSESSMENT PROGRAM QUALITY CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Toxicology

GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS

FDA 510(k)

FDA Class 2 ·Microbiology

MUMPS IGG ELISA TEST SYSTEM

FDA 510(k)

FDA Class 1 ·Microbiology

ROYAL SHIELD NON-STERILE BUBBLE GUM SCENTED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (5O

FDA 510(k)

FDA Class 1 ·General Hospital

ZQUIET MOUTHPIECE

FDA 510(k)

FDA Class 2 ·Dental

BIOMETRIC SCREW FIXATION CUP

FDA 510(k)

FDA Class 3 ·Orthopedic

Glidesheath Slender Tibial Pedal Kit

FDA 510(k)

FDA Class 2 ·Cardiovascular

4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

THE CHEN MEDIUM

FDA 510(k)

FDA Unclassified ·Unknown

ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM

FDA 510(k)

FDA Class 1 ·Microbiology

SENSIBEAD EIA DIGOXIN KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CLIRANS E-SERIES HOLLOW FIBER DIALYZERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BD GENEOHM VANR ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

HASELMEIER PEN

FDA 510(k)

FDA Class 2 ·General Hospital

NEER-III OSTEOARTHRITIS GLENOID RESURFACE PROSTHE.

FDA 510(k)

FDA Class 2 ·Orthopedic

BBLCRYSTAL GRAM-POSITIVE ID SYSTEM

FDA 510(k)

FDA Class 1 ·Microbiology

SAPPHIRE INFUSION PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

CAPIOX III CARDIOPULMONARY BYPASS OXYGENATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

BD BACTEC PLUS ANAEROBIC/F (PLASTIC)

FDA 510(k)

FDA Class 1 ·Microbiology

CHLORINATED, POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM

FDA 510(k)

FDA Class 1 ·General Hospital