CRYOcheck FVIII Inhibitor Kit— 510(k) K183440

Name: FDA 510(k) clearance K183440
Creator: U.S. Food and Drug Administration
Published: 2019-03-12

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.. Device class: 2.

Clearance details

Applicant: Precision Biologic, Inc.
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 2018-12-12
Decision date: 2019-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Darmouth, CA

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.