Antigen(Complexed),Prostate Specific,(Cpsa)

FDA Pre-Market Approval

FDA Class 3 ·IMMUNO 1 COMPLEXED PSA ASSAY

Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

FDA Pre-Market Approval

FDA Class 3 ·DAKO EGFR PHARMDX KIT

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY Anti-c-KIT (9.7) Primary Antibody

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY Anti-c-KIT (9.7) Primary Antibody

Antigen(Complexed),Prostate Specific,(Cpsa)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur cPSA Readypack Reagents

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY

Antigen(Complexed),Prostate Specific,(Cpsa)

FDA Pre-Market Approval

FDA Class 3 ·ACS: 180 AND ADVIA CENTAUR COMPLEXED PSA (CPSA) IMMUNOASSAYS

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY® Anti-c-KIT (9.7) Primary Antibody

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-C-KIT

Antigen(Complexed),Prostate Specific,(Cpsa)

FDA Pre-Market Approval

FDA Class 3 ·Atellica IM Complexed PSA (cPSA)

Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

FDA Pre-Market Approval

FDA Class 3 ·EGFR pharmDx

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·Pathway Anti-c-KIT (9.7) Rabbit Monoclonal Primary Antibody

Antigen(Complexed),Prostate Specific,(Cpsa)

FDA Pre-Market Approval

FDA Class 3 ·ACS:180 & ADVIA CENTAUR CPSA IMMUNOASSAYS

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·C-KIT PHARMDX

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY Anti-c-KIT (9.7) Primary Antibody

The AVEOtsd (Tongue Stabilizing Device) Mouthpiece

FDA 510(k)

FDA Class 2 ·Dental

EthanZir Zirconia

FDA 510(k)

FDA Class 2 ·Dental

CURETTE D/E GR 11-12 RIGID T/N HF HANDLE

FDA UDI

W.H. Holden, Inc.·D928705105RHFTN0·

CURETTE D/E GR 1-2 REG T/N HF HANDLE

FDA UDI

W.H. Holden, Inc.·D928705100TINHF0·

CURETTE D/E GR 3-4 RIGID T/N HF HANDLE

FDA UDI

W.H. Holden, Inc.·D928705101RHFTN0·