VENTANA EMA PRIMARY ANDIBODY— 510(k) K940243

Name: FDA 510(k) clearance K940243
Creator: U.S. Food and Drug Administration
Published: 1994-09-07

Substantially Equivalent

Ventana Medical Systems, Inc.

FDA 510(k) clearance K940243 for VENTANA EMA PRIMARY ANDIBODY, Substantially Equivalent on 1994-09-07. Applicant: Ventana Medical Systems, Inc.. Device class: 1.

Clearance details

Applicant: Ventana Medical Systems, Inc.
Product code: Code DHF
Device class: Class 1
Regulation: 21 CFR 866.5065
Advisory panel: Immunology
Date received: 1994-01-19
Decision date: 1994-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucson, AZ, US

Download summary PDF View on FDA.gov ↗

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