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

MACLIN POWER INTRAVASCULAR ADMINISTRATION SET

FDA 510(k)

FDA Class 2 ·General Hospital

LABELING CHANGE CANNABINOIDS DOUBLE ANTI. IN URINE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

GAMBRO MULTIPURPOSE SYSTEM MPS-10

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ALLEIA TOTAL IGE IRMA W/MONO. ANTI. RKIE 1,2,5

FDA 510(k)

FDA Class 2 ·Immunology

STANBIO SYPHILIS RPR TEST, NO. 1170

FDA 510(k)

FDA Class 2 ·Microbiology

SHIMADZU LATERAL C-ARM MH-31

FDA 510(k)

FDA Class 2 ·Radiology

MODIFIED DDI SEROCARD CMV IGG TEST KIT

FDA 510(k)

FDA Class 2 ·Microbiology