RADIUS AND SONOCHROME

FDA 510(k)

FDA Class 2 ·Radiology

MONOCLONAL ANTIBODY ANTI-CD2

FDA 510(k)

FDA Class 2 ·Hematology

MODIFIED IMIPENEM SUSCEPTIBILITY POWDER

FDA 510(k)

FDA Class 2 ·Microbiology

TANDEMR M-PAK LH IMMUNOENZYMETRIC ASSAY

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

FOLLICLE STIMULATING HORMONE (HFSH)

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

BIOSPOT HCG-RAPID PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TRANSESOPHAGEAL ECHO TRANSDUCER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IRMA-COUNT TSH RKTS1, RKTS2, RKTS5, RKTSX

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

EOSIN Y SOLUTION, ALCOHOLIC, WITH PHLOXINE

FDA 510(k)

FDA Class 1 ·Hematology

COMFORT CATH MALE EXTERNAL CATHETER

FDA 510(k)

FDA Class 1 ·Gastroenterology, Urology

TAMPAX PETAL SOFT DEODORANT TAMPON, SUPER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1057

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

RESUBMISSION OF URINE HEROIN/MORPHINE KIT [I-125]

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

TAMPAX CLOSED-END FLUSHABLE TAMPON, SLENDER REGU.

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SELENITE BROTH

FDA 510(k)

FDA Class 1 ·Microbiology

MCR4000 & MCR4000F CARDIOTOMY RESERVOIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

IMPRES-MB REAGENT A AND REAGENT B

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLS

FDA 510(k)

FDA Class 2 ·Hematology