AURAFLEX TESTOSTERONE CALIBRATOR PACK— 510(k) K951685
Substantially EquivalentOrganon Teknika Corp.
FDA 510(k) clearance K951685 for AURAFLEX TESTOSTERONE CALIBRATOR PACK, Substantially Equivalent on 1995-11-14. Applicant: Organon Teknika Corp.. Device class: 1.
Clearance details
- Applicant
- Organon Teknika Corp.
- Product code
- Code CDZ
- Device class
- Class 1
- Regulation
- 21 CFR 862.1680
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Durham, NC, US
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