COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·AMPLIFIED MTD (MYCOBACTERIUM TUBERCULOSIS DIRECT) TEST

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·AMPLIFIED MTD (MYCOBACTERIUM TUBERCULOSIS DIRECT) TEST

cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160

FDA 510(k)

FDA Class 2 ·Immunology

STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER

FDA 510(k)

FDA Class 2 ·Hematology

MEDICINA ENTERAL FEEDING TUBES AND ACCESSORIES MODEL MGX/YY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MD CO2 SURGICAL LASER SYSTEM/GEN. SURGERY AND ORTH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)

FDA 510(k)

FDA Class 2 ·Cardiovascular

CIRCON ACMI GEN SURG INSTRU FOR MINI INVASIVE SURG

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5

FDA 510(k)

FDA Class 2 ·Cardiovascular

DAVOL ENDO-FLO SUCT/IRRI PROBE (FOR GEN SURGERY)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFIED MSQ FAMILY OF LOVELY LIGHT/LASER SYSTEMS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ETEST SUBMISSION FOR AZITHROMYCIN/S. PNEUMONIAE

FDA 510(k)

FDA Class 2 ·Microbiology

ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322B

FDA 510(k)

FDA Class 2 ·Orthopedic

ETEST CHLORAMPHENICAL

FDA 510(k)

FDA Class 2 ·Microbiology