MDA D-DIMER— 510(k) K021877

Substantially Equivalent

bioMerieux, Inc.

FDA 510(k) clearance K021877 for MDA D-DIMER, Substantially Equivalent on 2002-08-07. Applicant: bioMerieux, Inc.. Device class: 2.

Clearance details

Applicant: bioMerieux, Inc.
Product code: Code GHH
Device class: Class 2
Regulation: 21 CFR 864.7320
Advisory panel: Hematology
Date received: 2002-06-07
Decision date: 2002-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.