510(k) K091969
- Device
- EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG)
- Applicant
- EUROIMMUN US INC
- 510(k) number
- K091969
- Product code
- NBO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-09-02
- Date received
- 2009-07-01
- Regulation
- 866.5660
- Classification name
- Autoantibodies, Skin (desmoglein 1 And Desmoglein 3)
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KATHRYN KOHL
- Address
- 95 Washington St. Morristown NJ US 07960 07960
FDA Registration Numbers#
- 3003268355
- 3007118747
- 3007361513
Source Documents#
Other 510(k) Records For Product Code NBO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K000336 | RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E | Rhigene, Inc. | 2000-06-09 |
Legacy Summary#
summary
FDA Review#
Decision Summary