EBV-EA IFA KIT— 510(k) K895652
Substantially EquivalentOrganon 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
- Code LSE
- Device class
- Class 1
- Regulation
- 21 CFR 866.3235
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Durham, NC, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.