EBV-EA IFA KIT— 510(k) K895652

Substantially Equivalent

Organon Teknika Treyburn

FDA 510(k) clearance K895652 for EBV-EA IFA KIT, Substantially Equivalent on 1989-12-18. Applicant: Organon Teknika Treyburn. Device class: 1.

Clearance details

Applicant: Organon Teknika Treyburn
Product code: Product code LSE
Device class: Class 1
Regulation: 21 CFR 866.3235
Advisory panel: Microbiology
Date received: 1989-09-20
Decision date: 1989-12-18
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.