DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL CALIBRATOR; MODELS K1167, KC212

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping

FDA 510(k)

FDA Class 2 ·Microbiology

DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K2125

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A

FDA 510(k)

FDA Class 2 ·Cardiovascular

PROSTHETIC RINGS #4400 MITRAL & 4500

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIASTAT VASCULAR ACCESS GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

BK-N SEALING CAP

FDA 510(k)

FDA Class 2 ·Cardiovascular

A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE

FDA 510(k)

FDA Class 2 ·Cardiovascular

AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARPENTIER-EDWARDS FLEX. ANNULOPLASTY

FDA 510(k)

FDA Class 2 ·Cardiovascular

CORFLO 300 PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

DIASTAT(TM) VASCULAR ACCESS GRAFT/CLASS III

FDA 510(k)

FDA Class 2 ·Cardiovascular

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit

FDA 510(k)

FDA Class 2 ·Microbiology

DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Emit II Plus Oxycodone Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit II Plus Specialty Drug Control Negative, Emit II Plus Specialty Drug Control Positive

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

AMPHETAMINE/METHAMPHETAMINE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS

FDA 510(k)

FDA Class 2 ·Hematology