PAP ANTIBODY KIT— 510(k) K924629

Substantially Equivalent

Ventana Medical Systems, Inc.

FDA 510(k) clearance K924629 for PAP ANTIBODY KIT, Substantially Equivalent on 1993-02-04. Applicant: Ventana Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Ventana Medical Systems, Inc.
Product code: Code DFD
Device class: Class 2
Regulation: 21 CFR 866.5550
Advisory panel: Immunology
Date received: 1992-09-14
Decision date: 1993-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucson, AZ, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.