Cleared Traditional

ENZYGNOST F+2 (MONOCLONAL) TEST KIT

K042687 · Dade Behring, Inc. · Hematology
Dec 2004
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K042687 is an FDA 510(k) clearance for the ENZYGNOST F+2 (MONOCLONAL) TEST KIT, a Prothrombin Fragment 1.2 (Class II — Special Controls, product code MIF), submitted by Dade Behring, Inc. (Newark,, US). The FDA issued a Cleared decision on December 10, 2004, 72 days after receiving the submission on September 29, 2004. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7320.

Submission Details

510(k) Number K042687 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2004
Decision Date December 10, 2004
Days to Decision 72 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code MIF — Prothrombin Fragment 1.2
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7320

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