Cleared Traditional

CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10

K982062 · Precision Biologicals, Inc. · Hematology
Jan 1999
Decision
212d
Days
Class 2
Risk

About This 510(k) Submission

K982062 is an FDA 510(k) clearance for the CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10, a Test, Time, Partial Thromboplastin (Class II — Special Controls, product code GGW), submitted by Precision Biologicals, Inc. (Dartmouth, Nova Scotia, CA). The FDA issued a Cleared decision on January 13, 1999, 212 days after receiving the submission on June 15, 1998. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7925.

Submission Details

510(k) Number K982062 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 1998
Decision Date January 13, 1999
Days to Decision 212 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGW — Test, Time, Partial Thromboplastin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7925

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