Cleared Traditional

MDA D-DIMER

K021877 · bioMerieux, Inc. · Hematology
Aug 2002
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K021877 is an FDA 510(k) clearance for the MDA D-DIMER, a Fibrin Split Products (Class II — Special Controls, product code GHH), submitted by bioMerieux, Inc. (Durham, US). The FDA issued a Cleared decision on August 7, 2002, 61 days after receiving the submission on June 7, 2002. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7320.

Submission Details

510(k) Number K021877 FDA.gov
FDA Decision Cleared SESE
Date Received June 07, 2002
Decision Date August 07, 2002
Days to Decision 61 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GHH — Fibrin Split Products
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7320

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