COAG-A-MATE(R) XM— 510(k) K881281
Substantially EquivalentOrganon Teknika Corp.
FDA 510(k) clearance K881281 for COAG-A-MATE(R) XM, Substantially Equivalent on 1988-05-18. Applicant: Organon Teknika Corp.. Device class: 2.
Clearance details
- Applicant
- Organon Teknika Corp.
- Product code
- Code GKP
- Device class
- Class 2
- Regulation
- 21 CFR 864.5400
- 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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