LACTATE DEHYDROGENASE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

POLYBONE

FDA 510(k)

FDA Class 2 ·Neurology

ALBUMIN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

M-46 GOLD BASE DENTAL ALLOY

FDA 510(k)

FDA Class 2 ·Dental

ATLAS IMPLANT SYSTEM- MINI PLUS

FDA 510(k)

FDA Class 2 ·Dental

BioCode Gastrointestinal Pathogen Panel (GPP)

FDA 510(k)

FDA Class 2 ·Microbiology

T-4 RIASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TOTAL BILIRUBIN REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE

FDA 510(k)

FDA Class 2 ·Ophthalmic

AST/SGOT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MYALLERGYTEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DONG BANG ACUPUNCTURE NEEDLES

FDA 510(k)

FDA Class 2 ·General Hospital

C-76 GOLD BASE DENTAL ALLOY

FDA 510(k)

FDA Class 2 ·Dental

POLYBONE GRANULE & BLOCK

FDA 510(k)

FDA Class 2 ·Orthopedic

TOTAL PROTEIN REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

T-3 UPTAKE/RIASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR HEPATITIS C VIRUS (HCV) TEST

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·FLEXTOME CUTTING BALLOON