FACTOR DEFICIENT SUBSTRATE PLASMA VIII— 510(k) K840928

Name: FDA 510(k) clearance K840928
Creator: U.S. Food and Drug Administration
Published: 1984-04-30

Substantially Equivalent

Diatech, Inc.

FDA 510(k) clearance K840928 for FACTOR DEFICIENT SUBSTRATE PLASMA VIII, Substantially Equivalent on 1984-04-30. Applicant: Diatech, Inc.. Device class: 2.

Clearance details

Applicant: Diatech, Inc.
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1984-03-02
Decision date: 1984-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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