Cleared Traditional

CRYOCHECK CLOT APCR

K060284 · Precision Biologic, Inc. · Hematology
May 2006
Decision
96d
Days
Class 2
Risk

About This 510(k) Submission

K060284 is an FDA 510(k) clearance for the CRYOCHECK CLOT APCR, a Test, Time, Partial Thromboplastin (Class II — Special Controls, product code GGW), submitted by Precision Biologic, Inc. (Dartmouth, N.S., CA). The FDA issued a Cleared decision on May 10, 2006, 96 days after receiving the submission on February 3, 2006. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7925.

Submission Details

510(k) Number K060284 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 2006
Decision Date May 10, 2006
Days to Decision 96 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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