EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CEDIA SIROLIMUS ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ARCHITECT SIROLIMUS ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Sirolimus Test System

FDA classification

FDA Class 2 ·Sirolimus Test System

E.N.S.I. RETRACTABLE SAFETY SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

PERMAGUM PUTTY SOFT & PERMAGUM GARRANT

FDA 510(k)

FDA Class 2 ·Dental

SHARPS CONTAINER

FDA 510(k)

FDA Class 2 ·General Hospital

ARP RX100

FDA 510(k)

FDA Class 2 ·Physical Medicine

ARP POV SPORT

FDA 510(k)

FDA Class 2 ·Physical Medicine

OPHTHAVISION IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4-RP (PROPOSED)

FDA 510(k)

FDA Class 2 ·Neurology

PRIMED TRACHEOSTOMY TUBES (MULTIPLE)

FDA 510(k)

FDA Class 2 ·Anesthesiology

PEACHTREE PROPORTIONAL HEAD CONTROL UNIT (PHC-3)

FDA 510(k)

FDA Class 2 ·Physical Medicine

PEACHTREE PROPORTIONAL HEAD CONTROL UNIT (PHC-2)

FDA 510(k)

FDA Class 2 ·Physical Medicine

I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02

FDA 510(k)

FDA Class 2 ·Hematology

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SEREINE WETTING & SOAKING SOLU. (NEW PRESERVATIVE)

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SEREINE CLEANER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SEREINE CONTACT LENS CLEANER (NEW PRESERVATIVE)