Cleared Traditional

CRYO CHECK INR VALIDATION SET

K971219 · Precision Biologicals, Inc. · Hematology
Aug 1997
Decision
149d
Days
Class 2
Risk

About This 510(k) Submission

K971219 is an FDA 510(k) clearance for the CRYO CHECK INR VALIDATION SET, a Plasma, Coagulation Control (Class II — Special Controls, product code GGN), submitted by Precision Biologicals, Inc. (Dartmouth, Nova Scotia, CA). The FDA issued a Cleared decision on August 29, 1997, 149 days after receiving the submission on April 2, 1997. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K971219 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 1997
Decision Date August 29, 1997
Days to Decision 149 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code GGN — Plasma, Coagulation Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425

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