Cleared Traditional

CRYOcheck Chromogenic Factor VIII

K251440 · Precision Biologic, Inc. · Hematology
Aug 2025
Decision
108d
Days
Class 2
Risk

About This 510(k) Submission

K251440 is an FDA 510(k) clearance for the CRYOcheck Chromogenic Factor VIII, a Test, Qualitative And Quantitative Factor Deficiency (Class II — Special Controls, product code GGP), submitted by Precision Biologic, Inc. (Dartmouth, CA). The FDA issued a Cleared decision on August 25, 2025, 108 days after receiving the submission on May 9, 2025. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K251440 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 2025
Decision Date August 25, 2025
Days to Decision 108 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGP — Test, Qualitative And Quantitative Factor Deficiency
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7290

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