DMA LD KINETIC PROCEDURE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GLUCOSE HK PROCEDURE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1

FDA 510(k)

FDA Class 2 ·Radiology

MULTIPURPOSE TRANSDUCER RANGE

FDA 510(k)

FDA Class 2 ·Radiology

MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V

FDA 510(k)

FDA Class 2 ·Cardiovascular

TOTAL BILIRUBIN PROCEDURE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NEO-FLOAT NEONATAL FLOTATION SYS & RHYT

FDA 510(k)

FDA Class 2 ·Physical Medicine

BICARBONATE PROCEDURE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Laser, Ophthalmic

FDA Pre-Market Approval

FDA Class 2 ·HYPERION LTK SYSTEM

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·TANDEM-R PSA IMMUNORADIOMETRIC ASSAY IMMUNOMETRIC TANDEM-E PSA IMMUNORADIOMETRIC ASSAY

SELISA ANTI-N DNA ANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)

FDA 510(k)

FDA Class 2 ·Immunology

UBI MAGIWEL(TM) ANTI-DS-DNA QUANTITATIVE

FDA 510(k)

FDA Class 2 ·Immunology

ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-DNA MICROASSAY

FDA 510(k)

FDA Class 2 ·Immunology

THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET

FDA 510(k)

FDA Class 2 ·Immunology

MULTIPLE (IZON DNA BLOOD COLLECTION KIT)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS)

FDA 510(k)

FDA Class 2 ·Immunology

LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213

FDA 510(k)

FDA Class 2 ·Immunology

DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology