AURAFLEX TPO-AB

FDA 510(k)

FDA Class 2 ·Immunology

AURAFLEX HCG

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IMX T3 ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·RAPIDSCREEN RS-2000

Bluemoon

FDA 510(k)

FDA Class 2 ·Dental

Complement 4d (C4d) And Complement Receptor 1 (Cr1)

FDA classification

FDA Class 2 ·Complement 4d (C4d) And Complement Receptor 1 (Cr1)

Antigen, Cf, B. Dermatitidis

FDA classification

FDA Class 2 ·Antigen, Cf, B. Dermatitidis

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER LX AND IMAGECHECKER DX (SOFTWARE VERSION 6.0)

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGE CHECKER M1000 SYSTEM

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·RAPIDSCREEN RS-2000D

Bottle, Collection, Breathing System (Calibrated)

FDA classification

FDA Class 2 ·Bottle, Collection, Breathing System (Calibrated)

Vaporizer, Anesthesia, Non-Heated

FDA classification

FDA Class 2 ·Vaporizer, Anesthesia, Non-Heated

System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

FDA classification

FDA Class 2 ·System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations