MODIFIED EXTRAVAKIT

FDA 510(k)

FDA Class 2 ·General Hospital

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

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

TAMPAX PETAL SOFT DEODORANT TAMPON, SUPER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

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

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

FACTOR V DEFICIENT PLASMA

FDA 510(k)

FDA Class 2 ·Hematology

MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY

FDA 510(k)

FDA Class 2 ·Cardiovascular

TAMPAX ORIGINAL REGULAR TAMPON

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

RAICHEM(TM) SPIA(TM) CRP REAGENT

FDA 510(k)

FDA Class 2 ·Immunology

MICROFILL PONTIC

FDA 510(k)

FDA Class 2 ·Dental