DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LITHOSKOP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604

FDA 510(k)

FDA Class 2 ·Immunology

REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529, REVEL DX INSERTABLE CARDIAC MONITOR, MODEL 9528

FDA 510(k)

FDA Class 2 ·Cardiovascular

STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE H.0

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDTRONIC C315 DELIVERY CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Dimension Hemoglobin A1c Assay

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION TACR CALIBRATOR, MODEL DC107

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ARTIS ZEE AND ZEEGO

FDA 510(k)

FDA Class 2 ·Radiology

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

FDA Pre-Market Approval

FDA Class 2 ·ACCESS HYBRITECH PSA REAGENTS ACCESS IMMUNOASSAY SYSTEMS

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

FDA Pre-Market Approval

FDA Class 2 ·ACCESS HYBRITECH PSA ON THE SYNCHRON LXI 725 SYSTEM

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

FDA Pre-Market Approval

FDA Class 2 ·TANDEM-R PSA IMMUNORADIOMETRIC ASSAY

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

FDA Pre-Market Approval

FDA Class 2 ·TANDEM-R PSA IMMUNORADIOMETRIC ASSAY

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

FDA Pre-Market Approval

FDA Class 2 ·TANDEM-R PSA IMMUNORADIOMETRIC ASSAY

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

FDA Pre-Market Approval

FDA Class 2 ·TANDEM-MP PSA IMMUNOENZYMETRIC ASSAY

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

FDA Pre-Market Approval

FDA Class 2 ·HYBRITECH(R) STRATUS(R) PSA ASSAY FLOUROMETRIC

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

FDA Pre-Market Approval

FDA Class 2 ·TANDEM-R PSA IMMUNORADIOMETRIC ASSAY

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

FDA Pre-Market Approval

FDA Class 2 ·ACCESS HYBRITECH PSA ON THE ACCESS 2 IMMUNOASSAY ANALYZER