BILIRUBIN(TOTAL) DETERMINATION CTMS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TOTAL THYROXINE (RIA) REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

KINETIC DETERMINATION OF UV GLUCOSE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Wrap Accessory Electrodes

FDA 510(k)

FDA Class 2 ·Neurology

HEMOGLOBIN ANALYZER & PERFORM. CHECK SET

FDA 510(k)

FDA Class 2 ·Hematology

T3 UPTAKE REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

(AST) OR (ALT) UV DETERM. PHY. PHOS.

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

UV GLUCOSE DETERM., AUTO CHEM. ANALYZERS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

UV URIC ACID STANDARDS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AST-UV (PLP-ACTIVATED) DETERMINATION

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COLORIMETRIC DETERMINATION (LDH)

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 ·COBAS AMPLIPREP / COBAS TAQMAN HCV TEST

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·QUANTUM MAVERICK OTW/APEX OTW/MAVERICK OTW/MAVERICK XL MONORAIL PTCA DILATATION CATHETERS

BILIRUBIN STANDARD-LYOPHILIZED

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LOWE KLEARWAY

FDA 510(k)

FDA Class 2 ·Dental

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK2 MONORAIL, MAVERICK (OTW), QUANTUM MAVERICK (OTW) PTCA CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK OTW (OVER-THE-WIRE) AND QUANTUM MAVERICK OTW

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MERLIN PTCA CATHETER OTW AND NC PTCA CATHETER OTW

ERCHONIA ML SCANNER (MLS)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology