Cleared Traditional

Cryocheck Hex LA

K193556 · Precision Biologic · Hematology
Oct 2020
Decision
305d
Days
Class 2
Risk

About This 510(k) Submission

K193556 is an FDA 510(k) clearance for the Cryocheck Hex LA, a Activated Partial Thromboplastin (Class II — Special Controls, product code GFO), submitted by Precision Biologic (Darmouth, CA). The FDA issued a Cleared decision on October 23, 2020, 305 days after receiving the submission on December 23, 2019. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7925.

Submission Details

510(k) Number K193556 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2019
Decision Date October 23, 2020
Days to Decision 305 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GFO — Activated Partial Thromboplastin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7925

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