iMac 27 & PL 4.0

FDA 510(k)

FDA Class 2 ·Radiology

COMPOSITE/COMPOMER REPAIR KIT

FDA 510(k)

FDA Class 2 ·Dental

DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN

FDA 510(k)

FDA Class 2 ·Immunology

FIBRINOGEN CALIBRATOR KIT

FDA 510(k)

FDA Class 2 ·Hematology

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500

FDA 510(k)

FDA Class 2 ·Hematology

STRATUS CS TROPONIN I CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY

FDA 510(k)

FDA Class 2 ·Radiology

DU PONT DIGOXIN ASSAY CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACA VANCOMYCIN (VANC) METHOD

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW AND CONTROL HIGH

FDA 510(k)

FDA Class 2 ·Immunology

ACA DU PONT URINE OPIATES (U OPI) SCREEN METHOD

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

FERRITIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INNOVANCE D-DIMER, MODEL OPBP09

FDA 510(k)

FDA Class 2 ·Hematology

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

DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BWF-5 MEDICAL LASER SERIES, 810 NM; 930 NM; 980 NM; 1080 NM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Emit® II Plus Buprenorphine Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600

FDA 510(k)

FDA Class 2 ·Immunology