Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Dimension Vista TPSA Flex reagent cartridge (K6451)

MONOHAEM (FECAL OCCULT BLOOD TEST)

FDA 510(k)

FDA Class 2 ·Hematology

PHENOBARBITAL FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

FILMSAVER, NT VERSION 5.03

FDA 510(k)

FDA Class 2 ·Radiology

CARDIOVASCULAR ARRAY

FDA 510(k)

FDA Class 2 ·Radiology

CPR MASK

FDA 510(k)

FDA Class 2 ·Anesthesiology

DIMENSION DRUG CALIBRATOR, MODEL DC22B

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

N LATEX STFR REAGENT

FDA 510(k)

FDA Class 2 ·Immunology

Plus Surgical Drapes (EO Sterilized), PMDB-XXX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

QUART ARTERIAL FILTER, MODEL HBF 140

FDA 510(k)

FDA Class 2 ·Cardiovascular

DUPONT DIMENSION(R) ETHYL ALCOHOL(ALC) METHOD

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

HERPTRAN CONCENTRATE

FDA 510(k)

FDA Class 2 ·Microbiology

BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2

FDA 510(k)

FDA Class 2 ·Hematology

DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Immunology

THYROID CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACA VANCOMYCIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000

FDA 510(k)

FDA Class 2 ·Hematology

Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry