NUCLISENS CMV PP67— 510(k) K983762

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K983762 for NUCLISENS CMV PP67, Substantially Equivalent on 1999-09-15. Applicant: Organon Teknika Corp.. Device class: 2.

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code LIN
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1998-10-26
Decision date: 1999-09-15
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.