Cleared Traditional

BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105

K043007 · Hyphen Biomed · Hematology
Nov 2005
Decision
371d
Days
Class 2
Risk

About This 510(k) Submission

K043007 is an FDA 510(k) clearance for the BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105, a Antithrombin Iii Quantitation (Class II — Special Controls, product code JBQ), submitted by Hyphen Biomed (Mason, US). The FDA issued a Cleared decision on November 7, 2005, 371 days after receiving the submission on November 1, 2004. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7060.

Submission Details

510(k) Number K043007 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 2004
Decision Date November 07, 2005
Days to Decision 371 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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