EMIT II PLUS ECSTASY ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Emit II Plus Cocaine Metabolite Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

FDA 510(k)

FDA Class 2 ·Microbiology

RPM RESPIRATORY GATING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

EMIT CAFFEINE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

PHILIPS TELEMEDICINE SERVER/SYSTEM, MODEL 861441

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,

FDA 510(k)

FDA Class 2 ·Microbiology

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