OT IGG SORBENT— 510(k) K934324
Substantially EquivalentOrganon Teknika Corp.
FDA 510(k) clearance K934324 for OT IGG SORBENT, Substantially Equivalent on 1994-04-21. Applicant: Organon Teknika Corp.. Device class: 2.
Clearance details
- Applicant
- Organon Teknika Corp.
- Product code
- Code DEW
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Durham, NC, US
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