Cleared Traditional

CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50

K023991 · Precision Biologic · Hematology
Apr 2003
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K023991 is an FDA 510(k) clearance for the CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50, a Antithrombin Iii Quantitation (Class II — Special Controls, product code JBQ), submitted by Precision Biologic (Dartmouth, N.S., CA). The FDA issued a Cleared decision on April 28, 2003, 146 days after receiving the submission on December 3, 2002. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7060.

Submission Details

510(k) Number K023991 FDA.gov
FDA Decision Cleared SESE
Date Received December 03, 2002
Decision Date April 28, 2003
Days to Decision 146 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JBQ — Antithrombin Iii Quantitation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7060

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