Cleared Traditional

BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6

K050367 · Hyphen Biomed · Hematology
May 2006
Decision
464d
Days
Class 2
Risk

About This 510(k) Submission

K050367 is an FDA 510(k) clearance for the BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6, a Assay, Heparin (Class II — Special Controls, product code KFF), submitted by Hyphen Biomed (Mason, US). The FDA issued a Cleared decision on May 24, 2006, 464 days after receiving the submission on February 14, 2005. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7525.

Submission Details

510(k) Number K050367 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 2005
Decision Date May 24, 2006
Days to Decision 464 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code KFF — Assay, Heparin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7525

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