Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA Centaur and Atellica IM HCV

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Atellica IM Analyzer Hepatitis C (aHCV)

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Atellica IM Hepatitis C (aHCV) Assay

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA Centaur HCV ReadyPack Reagents, Atellica IM Hepatitis C (aHCV), Atellica IM Hepatitis C Quality Control(aHCV QC)

CODE IM 2050 AMERLEX FREE T4 RIA KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAILING SYSTEM)

FDA 510(k)

FDA Class 2 ·Orthopedic

SCHILLER EKG COMBI MSG-IM SCOPE & RECORDER

FDA 510(k)

FDA Class 2 ·Cardiovascular

BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

Atellica® IM High-Sensitivity Troponin I (TnIH)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM)

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM)

FDA 510(k)

FDA Class 2 ·Orthopedic

VENTRESCREEN MITE/MOLD ALLERGY TEST KIT ENZYME IM.

FDA 510(k)

FDA Class 2 ·Immunology

BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Certa Dose Pediatric Midazolam 5mg/mL IM Syringe

FDA 510(k)

FDA Class 2 ·General Hospital

INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TEST

FDA 510(k)

FDA Class 2 ·Immunology

Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E

FDA 510(k)

FDA Class 2 ·General Hospital

Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107

FDA 510(k)

FDA Class 2 ·General Hospital

Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)

FDA 510(k)

FDA Class 2 ·General Hospital

Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G

FDA 510(k)

FDA Class 2 ·Cardiovascular

ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery