Cleared Traditional

CRYOCHECK CLOT C

K040987 · Precision Biologic, Inc. · Hematology
Jun 2004
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K040987 is an FDA 510(k) clearance for the CRYOCHECK CLOT C, a Test, Qualitative And Quantitative Factor Deficiency (Class II — Special Controls, product code GGP), submitted by Precision Biologic, Inc. (Dartmouth, N.S., CA). The FDA issued a Cleared decision on June 18, 2004, 64 days after receiving the submission on April 15, 2004. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K040987 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 2004
Decision Date June 18, 2004
Days to Decision 64 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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