EUROIMMUN ANTI-SLA/LP ELISA(LGG)
FDA 510(k) clearance K112221 · decided 2012-09-11
Clearance details
- K-number
- K112221
- Device name
- EUROIMMUN ANTI-SLA/LP ELISA(LGG)
- Applicant
- Euroimmun US
- Decision
- Substantially Equivalent
- Date received
- 2011-08-02
- Decision date
- 2012-09-11
- Days to decision
- 406 days
- Clearance type
- Traditional
- Product code
- NIY
- Device class
- 2
- Regulation number
- 866.5660
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Morris Plains, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG) (K113439) | Euroimmun US | 2013-04-12 |
| QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA (K021482) | Inova Diagnostics, Inc. | 2002-07-30 |
Recalls involving this device
No recalls on record reference this clearance.