DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFIED TECHNICON DPA-1(TM) SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

TECHNICON DPA-1 (TM) CRP METHOD

FDA 510(k)

FDA Class 2 ·Immunology

TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TECHNICON CHEM 1(TM) SYST (GEN2 SYST)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN

FDA 510(k)

FDA Class 2 ·Immunology

ALPHA1ANTITRYPSIN FOR TECHNICON DPA-1(TM) SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

TOSAMA Reusable Applicator

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CERULOPLASMIN FOR THE TECHNICON DPA-1(TM) SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

QWIK-1(TM) IN-LINE IV FLUID WARMER

FDA 510(k)

FDA Class 2 ·General Hospital

GO-PEN®

FDA 510(k)

FDA Class 2 ·General Hospital

COMPLEMENT C4 FOR THE TECHNICON DPA-1(TM) SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

PROPERDIN FACTOR B FOR TECHNICON DPA-1(TM) SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED COYOTE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS RX COMET CORONARY DILATION CATHETER

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·BAYER IMMUNO 1 SYSTEM

SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·RX CHASSIS I CORONARY DILATATION CATHETER