DRI METHADONE METABOLITE ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BACTIDROP(TM) NITRATE A

FDA 510(k)

FDA Class 1 ·Microbiology

ETEST LINEZOLID

FDA 510(k)

FDA Class 2 ·Microbiology

ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-899XT

FDA 510(k)

FDA Class 2 ·Orthopedic

ARTHREX BIO-POST AND WASHER

FDA 510(k)

FDA Class 2 ·Orthopedic

IRRIGA SUC ILLUM ISIS 710 & 7100 SERIES

FDA 510(k)

SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN

FDA 510(k)

FDA Class 3 ·Cardiovascular

VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP

FDA 510(k)

FDA Class 2 ·Microbiology

SYSTEM U3

FDA 510(k)

FDA Class 2 ·Microbiology

VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

BACTIDROP (TM) NITRATE B

FDA 510(k)

FDA Class 1 ·Microbiology

SYSTEM U3 FOR NORFLOXACIN

FDA 510(k)

FDA Class 2 ·Microbiology

FORA GTel Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BACTIGEN(R) S. PNEUMONIAE

FDA 510(k)

FDA Class 1 ·Microbiology

ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS

FDA 510(k)

FDA Class 2 ·Radiology

KIMBERLY-CLARK CHILD'S FACEMASK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACCU-CHEK ADVANTAGE BLOOD GLUCOSE SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

URINARY DRAINAGE CONTAINER 2013 WITH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology