AURATEK FDP— 510(k) K943787

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K943787 for AURATEK FDP, Substantially Equivalent on 1994-09-20. 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: 1994-08-03
Decision date: 1994-09-20
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.