VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & V

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1, AND DAT PERFORMANCE VERIFIERS I, II, III, IV

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

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

FIDELIS PLUS III D, AT FIDELIS D, POWERLASE AT D / FIDELIS PLUS III, AT FIDELIS, POWERLASE AT / FIDELIS ER III D, HT FID

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Dna Genetic Analyzer

FDA classification

FDA Class 2 ·Dna Genetic Analyzer

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·PowerLook® Tomo Detection Software

Catheter, Flow Directed

FDA Pre-Market Approval

FDA Class 2 ·VOYAGER OTW CORONARY DILATION CATHETER

Catheter, Flow Directed

FDA Pre-Market Approval

FDA Class 2 ·RX CHASSIS 3 CORONARY DILATATION CATHETER

Catheter, Flow Directed

FDA Pre-Market Approval

FDA Class 2 ·ESPRIT/CROSSAIL/OPENSAIL/POWERSAIL/HIGHSAIL CORONARY DILATION CATHETHERS

Catheter, Flow Directed

FDA Pre-Market Approval

FDA Class 2 ·HIGHSAIL CORONARY DILATATION CATHETERS

Azo Dye, Calcium

FDA classification

FDA Class 2 ·Azo Dye, Calcium

Bracket, Plastic, Orthodontic, Reprocessed

FDA classification

FDA Class 2 ·Bracket, Plastic, Orthodontic, Reprocessed

Ventilator, External Body, Negative Pressure, Adult (Cuirass)

FDA classification

FDA Class 2 ·Ventilator, External Body, Negative Pressure, Adult (Cuirass)

Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control

Starch-Dye Bound Polymer, Amylase

FDA classification

FDA Class 2 ·Starch-Dye Bound Polymer, Amylase

Bromcresol Purple Dye-Binding, Albumin

FDA classification

FDA Class 2 ·Bromcresol Purple Dye-Binding, Albumin

Bromcresol Green Dye-Binding, Albumin

FDA classification

FDA Class 2 ·Bromcresol Green Dye-Binding, Albumin

Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase

FDA classification

FDA Class 2 ·Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase