510(k) K132195
- Device
- EUROIMMUN ANTI-PLA2R ELISA (IGG)
- Applicant
- EUROIMMUN US INC
- 510(k) number
- K132195
- Product code
- PGV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-06-27
- Date received
- 2013-07-15
- Regulation
- 866.5780
- Classification name
- Anti-phospholipase A2 Receptor
- Medical specialty
- Microbiology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL LOCKE
- Address
- 1100 The American Rd. Morris Plains NJ US 07950 07950
FDA Registration Numbers#
- 3007118747
- 3007361513
- 3003268355
Source Documents#
Other 510(k) Records For Product Code PGV #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN140002 | EUROIMMUN ANTI-PLA2R IFA | Euroimmun US | 2014-05-29 |
Legacy Summary#
summary
FDA Review#
Decision Summary