EUROIMMUN ANTI-PLA2R IFA
FDA 510(k) clearance DEN140002 · decided 2014-05-29
Clearance details
- K-number
- DEN140002
- Device name
- EUROIMMUN ANTI-PLA2R IFA
- Applicant
- Euroimmun US
- Decision
- Unknown
- Date received
- 2014-03-28
- Decision date
- 2014-05-29
- Days to decision
- 62 days
- Clearance type
- Post-NSE
- 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 ELISA (IGG) (K132195) | Euroimmun Us, Inc. | 2014-06-27 |
Recalls involving this device
No recalls on record reference this clearance.