AIA-PACK CTNI 2ND-GEN ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TOTAL PROTEIN URINE/CSF GEN.3

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BD Nano 2nd Gen Pen Needle

FDA 510(k)

FDA Class 2 ·General Hospital

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST(MTD TEST)

Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODEL 4100 14 MEV NEUTRON GEN. THERAPY

FDA 510(k)

FDA Class 2 ·Radiology

COMPRESSED AIR & OXYGEN GEN./DELIVERY SY

FDA 510(k)

FDA Class 2 ·Anesthesiology

ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRES

FDA 510(k)

FDA Class 2 ·Cardiovascular

ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2

FDA 510(k)

FDA Class 2 ·Immunology

Tina-quant Lipoprotein(a) Gen.2 Molarity

FDA 510(k)

FDA Class 2 ·Immunology

HI-LO TEMP GEN. PURPOSE TEMP. PROBE

FDA 510(k)

FDA Class 2 ·General Hospital

ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2

FDA 510(k)

FDA Class 2 ·Immunology

ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2

FDA 510(k)

FDA Class 2 ·Immunology

Personal Kinetigraph (PKG) System Gen 2 Plus

FDA 510(k)

FDA Class 2 ·Neurology

NC° Thermometer (Gen 3), Model Number: NCTG3

FDA 510(k)

FDA Class 2 ·General Hospital

TINA-QUANT HBA1C GEN. 2 TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST

FDA 510(k)

FDA Class 2 ·Hematology

VISUAL PATTERN REVERSAL GEN. & PHOTIC S.

FDA 510(k)

FDA Class 2 ·Neurology