Atellica® IM High-Sensitivity Troponin I (TnIH)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC

FDA 510(k)

FDA Class 2 ·Immunology

Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

GentleCath Glide Intermittent Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01

FDA 510(k)

FDA Class 2 ·Microbiology

LIFESYS PACS

FDA 510(k)

FDA Class 2 ·Radiology

PHARMACIA IGE RIA MODIFIED

FDA 510(k)

FDA Class 2 ·Immunology

SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT

FDA 510(k)

FDA Class 2 ·Immunology

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

FDA 510(k)

FDA Class 2 ·Immunology

IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF4064

FDA 510(k)

FDA Class 2 ·Immunology

IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH

FDA 510(k)

FDA Class 2 ·Immunology

IGE ENZYME IMMUNOASSAY TEST KIT NO. MB-1064

FDA 510(k)

FDA Class 2 ·Immunology

TIMOTHY ALLERGEN DISC

FDA 510(k)

FDA Class 2 ·Immunology

VAST VENTREX RAST ALLERGEN DISCS

FDA 510(k)

FDA Class 2 ·Immunology

QUANTIA IGE

FDA 510(k)

FDA Class 2 ·Immunology

PHARMACIA IGE RIA

FDA 510(k)

FDA Class 2 ·Immunology