CRYOcheck FVIII Inhibitor Kit— 510(k) K183440

Substantially Equivalent

Precision Biologic, Inc.

FDA 510(k) clearance K183440 for CRYOcheck FVIII Inhibitor Kit, Substantially Equivalent on 2019-03-12. Applicant: Precision Biologic, Inc..

Clearance details

Applicant: Precision Biologic, Inc.
Product code: Code GGP
Advisory panel: Hematology
Date received: 2018-12-12
Decision date: 2019-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Darmouth, CA

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