EUROIMMUN ANTI-PLA2R ELISA (IGG)
FDA 510(k) clearance K132195 · decided 2014-06-27
Clearance details
- K-number
- K132195
- Device name
- EUROIMMUN ANTI-PLA2R ELISA (IGG)
- Applicant
- Euroimmun Us, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-07-15
- Decision date
- 2014-06-27
- Days to decision
- 347 days
- Clearance type
- Traditional
- Product code
- PGV
- Device class
- 2
- Regulation number
- 866.5780
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- 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 ANTI-PLA2R IFA (DEN140002) | Euroimmun US | 2014-05-29 |
Recalls involving this device
No recalls on record reference this clearance.