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

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS TOTAL PSA IMMUNOASSAY/TOTAL PSA CALSET

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

FDA Pre-Market Approval

FDA Class 2 ·IMMULITE 2500 PSA, IMMULITE 2500 THIRD GENERATION PSA

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

FDA Pre-Market Approval

FDA Class 2 ·IMMULITE/IMMULITE 1000 PSA & 1000 THIRD GENERATION PSA

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

FDA Pre-Market Approval

FDA Class 2 ·AIA-PACK PA PSA, ST AIA-PACK PA PSA

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

FDA Pre-Market Approval

FDA Class 2 ·TANDEM-R PSA & TANDEM-E PSA IMMUNOENZYMETRIC ASSAY

DISTAT ANTI-DSDNA KIT

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-CARDIOLIPIN KIT

FDA 510(k)

FDA Class 2 ·Immunology

SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY

FDA 510(k)

FDA Class 2 ·Hematology

VPAP Adapt SV, VPAP Tx, S9 VPAP Tx

FDA 510(k)

FDA Class 2 ·Anesthesiology

DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-CENTROMERE KIT

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-CARDIOLIPIN KIT

FDA 510(k)

FDA Class 2 ·Immunology

NEUROMONICS TINNITUS TREATMENT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05

FDA 510(k)

FDA Class 2 ·Hematology

UniPulse

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT

FDA 510(k)

FDA Class 2 ·Immunology

DISTAT ANTI-SCL-70 KIT

FDA 510(k)

FDA Class 2 ·Immunology

AirPhysio Positive Expiratory Pressure (PEP) Device

FDA 510(k)

FDA Class 2 ·Anesthesiology

ANMP (ACOUSTIC NEURO MODULATION PROTOCOL)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

DIASTAT ANTI-HISTONE KIT

FDA 510(k)

FDA Class 2 ·Immunology