Rickettsia Real-time PCR Assay

FDA 510(k)

FDA Class 2 ·Microbiology

CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping

FDA 510(k)

FDA Class 2 ·Microbiology

Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040)

FDA 510(k)

FDA Class 2 ·Cardiovascular

DC-8/DC-8 PRO/DC-8, CV/DC-8, EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

DC-8/ DC-8 PRO/ DC-8 CV/ DC-8 EXP/ DC-8S DIAGNOSTIC ULTRASOUND SYSTEMS

FDA 510(k)

FDA Class 2 ·Radiology

URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HEALTHTRONIC OMEGA TRAC

FDA 510(k)

FDA Class 2 ·Physical Medicine

OFNat Lubricant (L15)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Microthin Natural Rubber Latex Condom

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM.

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

SERA-TEK THYROGLOBULIN ANTIBODY TEST

FDA 510(k)

FDA Class 2 ·Immunology

THYMUNE-T

FDA 510(k)

FDA Class 2 ·Immunology

ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895

FDA 510(k)

FDA Class 2 ·Immunology

SERAQUEST ANTI-THYROGLOBULIN

FDA 510(k)

FDA Class 2 ·Immunology

THYMUNE-M

FDA 510(k)

FDA Class 2 ·Immunology

THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology