CRYOcheck Chromogenic Factor IX— 510(k) K214002

Substantially Equivalent

Precision Biologic, Inc.

FDA 510(k) clearance K214002 for CRYOcheck Chromogenic Factor IX, Substantially Equivalent on 2022-12-23. Applicant: Precision Biologic, Inc..

Clearance details

Applicant: Precision Biologic, Inc.
Product code: Code GGP
Advisory panel: Hematology
Date received: 2021-12-21
Decision date: 2022-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Darmouth, CA

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