Cleared Traditional

CRYOcheck Factor VIII Deficient Plasma with VWF

K222831 · Precision Biologic, Inc. · Hematology
Sep 2023
Decision
359d
Days
Class 2
Risk

About This 510(k) Submission

K222831 is an FDA 510(k) clearance for the CRYOcheck Factor VIII Deficient Plasma with VWF, a Plasma, Coagulation Factor Deficient (Class II — Special Controls, product code GJT), submitted by Precision Biologic, Inc. (Darmouth, CA). The FDA issued a Cleared decision on September 13, 2023, 359 days after receiving the submission on September 19, 2022. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K222831 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 2022
Decision Date September 13, 2023
Days to Decision 359 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GJT — Plasma, Coagulation Factor Deficient
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7290

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