510(k) K000336
- Device
- RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E
- Applicant
- RHIGENE, INC.
- 510(k) number
- K000336
- Product code
- NBO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-06-09
- Date received
- 2000-02-03
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVE KOLESAR
- Address
- 455 State St., Suite 104 Des Plaines IL US 60068 60068
FDA Registration Numbers#
- 3003268355
- 3007118747
- 3007361513
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NBO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K091969 | EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG) | Euroimmun Us, Inc. | 2010-09-02 |
Legacy Summary#
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FDA Review#
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