Cleared Traditional

CRYO CHECK FACTOR V DEFICIENT PLASMA

K971223 · Precision Biologicals, Inc. · Hematology
Jul 1997
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K971223 is an FDA 510(k) clearance for the CRYO CHECK FACTOR V DEFICIENT PLASMA, a Plasma, Coagulation Factor Deficient (Class II — Special Controls, product code GJT), submitted by Precision Biologicals, Inc. (Dartmouth, Nova Scotia, CA). The FDA issued a Cleared decision on July 22, 1997, 111 days after receiving the submission on April 2, 1997. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K971223 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 1997
Decision Date July 22, 1997
Days to Decision 111 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code GJT — Plasma, Coagulation Factor Deficient
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7290

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