EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)
FDA 510(k) clearance K183313 · decided 2019-02-28
Clearance details
- K-number
- K183313
- Device name
- EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)
- Applicant
- Euroimmun Us, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-11-29
- Decision date
- 2019-02-28
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- MVM
- Device class
- 2
- Regulation number
- 866.5660
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Mountain Lakes, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.