EPISCREEN— 510(k) K970357

Substantially Equivalent

Epitope, Inc.

FDA 510(k) clearance K970357 for EPISCREEN, Substantially Equivalent on 1997-03-10. Applicant: Epitope, Inc.. Device class: 2.

Clearance details

Applicant: Epitope, Inc.
Product code: Code PJD
Device class: Class 2
Regulation: 21 CFR 862.1675
Advisory panel: Clinical Chemistry
Date received: 1997-01-30
Decision date: 1997-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaverton, OR, US

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