CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)

FDA 510(k)

FDA Class 2 ·Hematology

CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15

FDA 510(k)

FDA Class 2 ·Hematology

CRYOCHECK CLOT C

FDA 510(k)

FDA Class 2 ·Hematology

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·NDS LENS MAINTENANCE SYSTEM

EUROTROL HEMATOCRIT CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

SIGNET DXIS DIRECT X-RAY IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

PHILIPS HERCEPTEST DIGITAL SCORE

FDA 510(k)

FDA Class 2 ·Hematology

THROMBOPLASTIN

FDA 510(k)

FDA Class 2 ·Hematology

APTT REAGENT

FDA 510(k)

FDA Class 2 ·Hematology

DeltaScan Patch

FDA 510(k)

FDA Class 2 ·Neurology

COAGULATION CONTROL PLASMA (NORMAL & ABNORMAL)

FDA 510(k)

FDA Class 2 ·Hematology

Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)

FDA classification

FDA Class 2 ·Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)

Hiv-1 Genotyping Assay Using Ngs Technology

FDA classification

FDA Class 2 ·Hiv-1 Genotyping Assay Using Ngs Technology

Tympanometer, Exempt

FDA classification

FDA Class 2 ·Tympanometer, Exempt