N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC

FDA 510(k)

FDA Class 2 ·Immunology

Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

GentleCath Glide Intermittent Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Emit® II Plus Buprenorphine Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TUF-COAT

FDA 510(k)

FDA Class 2 ·Dental

G-CERA PORCELAIN & G-CERA PORCELAIN MODIFIER

FDA 510(k)

FDA Class 2 ·Dental

UNIFAST LC

FDA 510(k)

FDA Class 2 ·Dental

FUJI LINING CEMENT LIGHT CURE

FDA 510(k)

FDA Class 2 ·Dental

MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULES

FDA 510(k)

FDA Class 2 ·Dental

RESUBMITTED EMA DENTIN CEMENT

FDA 510(k)

FDA Class 2 ·Dental

76 ELW BITE CHECKER SILICONE

FDA 510(k)

FDA Class 2 ·Dental