Cryocheck Chromogenic Factor VIII— 510(k) K193204

Name: FDA 510(k) clearance K193204
Creator: U.S. Food and Drug Administration
Published: 2020-07-17

Substantially Equivalent

Precision Biologic

FDA 510(k) clearance K193204 for Cryocheck Chromogenic Factor VIII, Substantially Equivalent on 2020-07-17. Applicant: Precision Biologic. Device class: 2.

Clearance details

Applicant: Precision Biologic
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 2019-11-20
Decision date: 2020-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Darmouth, CA

Download summary PDF View on FDA.gov ↗

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