Cleared Traditional

CRYOcheck Chromogenic Factor IX

K214002 · Precision Biologic, Inc. · Hematology
Dec 2022
Decision
367d
Days
Class 2
Risk

About This 510(k) Submission

K214002 is an FDA 510(k) clearance for the CRYOcheck Chromogenic Factor IX, a Test, Qualitative And Quantitative Factor Deficiency (Class II — Special Controls, product code GGP), submitted by Precision Biologic, Inc. (Darmouth, CA). The FDA issued a Cleared decision on December 23, 2022, 367 days after receiving the submission on December 21, 2021. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K214002 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2021
Decision Date December 23, 2022
Days to Decision 367 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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