EPISCREEN ORAL SPECIMEN COLLECTION DEVICE— 510(k) K973395

Name: FDA 510(k) clearance K973395
Creator: U.S. Food and Drug Administration
Published: 1998-02-13

Substantially Equivalent

Epitope, Inc.

FDA 510(k) clearance K973395 for EPISCREEN ORAL SPECIMEN COLLECTION DEVICE, Substantially Equivalent on 1998-02-13. 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: 1997-08-21
Decision date: 1998-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaverton, OR, US

Download summary PDF View on FDA.gov ↗

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