510(k) DEN140002
- Device
- EUROIMMUN ANTI-PLA2R IFA
- Applicant
- Euroimmun US
- 510(k) number
- DEN140002
- Product code
- PGV
- Decision
- Unknown (DENG)
- Decision date
- 2014-05-29
- Date received
- 2014-03-28
- Regulation
- 866.5780
- Classification name
- Anti-Phospholipase A2 Receptor
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- MICHAEL LOCKE
- Address
- 1100 The American Rd. Morris Plains NJ US 07950 07950
FDA Registration Numbers#
- 3003268355
- 3007118747
- 3007361513
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PGV#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K132195 | EUROIMMUN ANTI-PLA2R ELISA (IGG) | Euroimmun Us, Inc. | 2014-06-27 |