ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3

FDA 510(k)

FDA Class 2 ·Immunology

THERATEST EL-ANTI-CCP/2

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE CCP3 IGG ELISA

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE CCP ELISA

FDA 510(k)

FDA Class 2 ·Immunology

MULTI-ANALYTE DETECTION SYSTEMS

FDA 510(k)

FDA Class 2 ·Immunology

IMMUNOSCAN CCPLUS

FDA 510(k)

FDA Class 2 ·Immunology

AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10

FDA 510(k)

FDA Class 2 ·Immunology

ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.

FDA 510(k)

FDA Class 2 ·Immunology

AXIS-SHIELD ANTI-CCP

FDA 510(k)

FDA Class 2 ·Immunology

BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP

FDA 510(k)

FDA Class 2 ·Immunology

SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

AXYA MEDICAL INC, BONE ANCHOR SYSTEM AND KIT- (BAK)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MEDI-CULT PVP MEDIUM, MEDI-CULT PVP CLINICAL GRADE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MEDI-CULT FREEZING & THAWING PACKS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ICSI CUMULASE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SUTURE WELDING SYSTEM AND KIT (SWK)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery