Cleared Traditional

CRYOcheck FVIII Inhibitor Kit

K183440 · Precision Biologic, Inc. · Hematology
Mar 2019
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K183440 is an FDA 510(k) clearance for the CRYOcheck FVIII Inhibitor Kit, 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 March 12, 2019, 90 days after receiving the submission on December 12, 2018. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K183440 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 2018
Decision Date March 12, 2019
Days to Decision 90 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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