VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody— 510(k) DEN170030

Name: FDA 510(k) clearance DEN170030
Creator: U.S. Food and Drug Administration
Published: 2017-10-27

Unknown

Ventana Medical Systems

FDA 510(k) clearance DEN170030 for VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody, Unknown on 2017-10-27. Applicant: Ventana Medical Systems. Device class: 2.

Clearance details

Applicant: Ventana Medical Systems
Product code: Code PZJ
Device class: Class 2
Regulation: 21 CFR 864.1866
Advisory panel: Immunology
Date received: 2017-05-30
Decision date: 2017-10-27
Decision: Unknown
Clearance type: Direct
Location: Tucson, AZ, US

View on FDA.gov ↗

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