EUROIMMUN ANTI-M2-3E ELISA (IGG)
FDA 510(k) clearance K092736 · decided 2010-09-02
Clearance details
- K-number
- K092736
- Device name
- EUROIMMUN ANTI-M2-3E ELISA (IGG)
- Applicant
- Euroimmun Us, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-09-04
- Decision date
- 2010-09-02
- Days to decision
- 363 days
- Clearance type
- Traditional
- Product code
- DBM
- Device class
- 2
- Regulation number
- 866.5090
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Morristown, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.