Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ORAQUICK HCV RAPID ANTIBODY TEST

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·OraQuick HCV Rapid Antibody Test

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA classification

FDA Class 2 ·Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACCUSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BAR/BZO, SYVA RAPIDTEST D.A.U. 2 BAR/BZO

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ANGEL WING SAFETY BLOOD COLLECTION AND INFUSION SE

FDA 510(k)

FDA Class 2 ·General Hospital

ANGEL WING SAFETY BLOOD COLLECTION WITH TUBE HOLD.

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ANGEL WING SETS -- MODIFIED

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACCUSIGN DOA 3/DOA 3 (BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA 3/BZO/BAR/PCP, BIOSIGN BZO/BAR/PCP

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CALCIUM, AZO DYE REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VERDICT -II BAR/BZO

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

IMZ O-RING ATTACHMENT

FDA 510(k)

FDA Class 2 ·Dental

ACCUSIGN DOA3, DOA, BAR/BZO/MTD, BIOSIGN DOA3, BIOSIGN BAR/BZO/MTD

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LED Curing Light (C01-X, C02-X)

FDA 510(k)

FDA Class 2 ·Dental

Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Self-Fitting hearing aids

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Disposable Endoscopic Cutter Stapler and Cartridge

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Aneroid Sphygmomanometer

FDA 510(k)

FDA Class 2 ·Cardiovascular

Non-Contact Forehead Thermometer (Models UT306H & UT308H)

FDA 510(k)

FDA Class 2 ·General Hospital