ANA ANTISERA CONTROL KIT

FDA 510(k)

FDA Class 2 ·Immunology

MODIFIED ACCESS R-CLONE ANA/RF SCREENING TEST

FDA 510(k)

FDA Class 2 ·Immunology

RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

AC3 Series Intra-Aortic Balloon Pump (IABP)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACCESS R-CLONE ANA PROFILE ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

RHEUMELISA ASSAY FOR SM AUTOANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

TECHNICON DAX SYSTEM THYROXINE (T4) METHOD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TECHNICON DAX SYSTEM - SODIUM (ISE) METHOD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TECHNICON DAX SYSTEM - POTASSIUM (ISE) METHOD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Wishbone HA

FDA 510(k)

FDA Class 2 ·Dental

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

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV

Sinobot X1

FDA 510(k)

FDA Class 2 ·Neurology

END 200 Endoscopic Tubeset

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EndoFLIP® System with FLIP Topography module

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EsoFLIP® ES-310 Balloon Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LDH ISOENZYME CONTROL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ULTRACHEM T.P.

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CENTRIFICHEM CREATININE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry