ANTI-MUTATED CITRULLINATED VIMENTIN EIA
FDA 510(k) clearance K092399 · decided 2010-07-01
Clearance details
- K-number
- K092399
- Device name
- ANTI-MUTATED CITRULLINATED VIMENTIN EIA
- Applicant
- Orgentec Diagnostika GmbH
- Decision
- Substantially Equivalent
- Date received
- 2009-08-06
- Decision date
- 2010-07-01
- Days to decision
- 329 days
- Clearance type
- Traditional
- Product code
- OQZ
- Device class
- 2
- Regulation number
- 866.5775
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- East Stroudsburg, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.