Cleared Traditional

CRYOCHECK CLOT S

K043571 · Precision Biologic, Inc. · Hematology
Mar 2005
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K043571 is an FDA 510(k) clearance for the CRYOCHECK CLOT S, 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 March 18, 2005, 81 days after receiving the submission on December 27, 2004. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K043571 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 2004
Decision Date March 18, 2005
Days to Decision 81 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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