MDA D-DIMER— 510(k) K000492

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K000492 for MDA D-DIMER, Substantially Equivalent on 2000-06-07. Applicant: Organon Teknika Corp.. Device class: 2.

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code DAP
Device class: Class 2
Regulation: 21 CFR 864.7320
Advisory panel: Hematology
Date received: 2000-02-15
Decision date: 2000-06-07
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.