Cleared Traditional

Cryocheck Chromogenic Factor VIII

K193204 · Precision Biologic · Hematology
Jul 2020
Decision
240d
Days
Class 2
Risk

About This 510(k) Submission

K193204 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 (Darmouth, CA). The FDA issued a Cleared decision on July 17, 2020, 240 days after receiving the submission on November 20, 2019. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K193204 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 2019
Decision Date July 17, 2020
Days to Decision 240 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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