Hemoglobin For Donor Testing

FDA classification

FDA Class 2 ·Hemoglobin For Donor Testing

OREAI-Q-TU TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

QCU ANALYTICAL SOFTWARE PACKAGE

FDA 510(k)

FDA Class 2 ·Radiology

QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT)

FDA 510(k)

FDA Class 2 ·Radiology

QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS)

FDA 510(k)

FDA Class 2 ·Radiology

AUTOQUANT QUANTITATIVE PERFUSION SPECT (QPS) & QUANTITATIVE GATED SPECT (QGS)

FDA 510(k)

FDA Class 2 ·Radiology

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)

FDA 510(k)

FDA Class 2 ·Dental

SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SAFECARE® THC Urine Strip Test

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Powered Muscle Stimulator (Model name:MagGraver F200)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Ancora Nerve Block Catheter Set

FDA 510(k)

FDA Class 2 ·Anesthesiology

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Pelvic Floor Muscle Stimulator

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Nexpowder

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PuraStat-GI

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery