MDA HEPARIN ANTI-X ASSAY— 510(k) K965076
Substantially EquivalentOrganon Teknika Corp.
FDA 510(k) clearance K965076 for MDA HEPARIN ANTI-X ASSAY, Substantially Equivalent on 1997-03-18. Applicant: Organon Teknika Corp.. Device class: 2.
Clearance details
- Applicant
- Organon Teknika Corp.
- Product code
- Code KFF
- Device class
- Class 2
- Regulation
- 21 CFR 864.7525
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Durham, NC, US
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More clearances from Organon Teknika Corp.
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