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

MITEK MINI ANCHOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MITEK ABSORBABLE ANCHOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

STERICHEK BICARB PH REAGENT STRIPS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ABSORBALBE ANCHOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SERIM(TM) BICARB PH REAGENT STRIPS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Peripheral Intravenous (Piv) Infiltration Monitor

FDA classification

FDA Class 2 ·Peripheral Intravenous (Piv) Infiltration Monitor

Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay

FDA classification

FDA Class 2 ·Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay

ASTRA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BAKER DIAG. ULTRARATE CO2 REAGENT KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry