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

Catheter, Peritoneal Dialysis, Single Use, Exempt

FDA classification

FDA Class 2 ·Catheter, Peritoneal Dialysis, Single Use, Exempt

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

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·LOGICON CARIES DETECTOR

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PTCA CATHETERS

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLICOR HCV TEST, VERSION 2.0 AND COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·AFFINITY ANTERIOR CERVICAL CAGE SYSTEM