DIAPHARMA FACTOR X KIT— 510(k) K040362

Substantially Equivalent

Diapharma Group, Inc.

FDA 510(k) clearance K040362 for DIAPHARMA FACTOR X KIT, Substantially Equivalent on 2004-07-12. Applicant: Diapharma Group, Inc.. Device class: 2.

Clearance details

Applicant: Diapharma Group, Inc.
Product code: Code GJT
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 2004-02-13
Decision date: 2004-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, OH, US

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