Euroimmun Anti-Desmoglein 1 Elisa (Igg), Euroimmun Anti-Desmoglein 3 Elisa (Igg)
FDA 510(k) K091969 · Euroimmun Us, Inc.
510(k) numberK091969
Submission
- Device name
- Euroimmun Anti-Desmoglein 1 Elisa (Igg), Euroimmun Anti-Desmoglein 3 Elisa (Igg)
- Applicant
- Euroimmun Us, Inc.
Morristown, NJ, US - Received
- July 1, 2009
- Decision date
- September 2, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NBO – Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5660
- Specialty
- Immunology
Other 510(k)s with product code NBO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K000336 | Rhigene DSG-1 & DSG-3 Elisa Test System, Model 7680 ENBO · Traditional | Rhigene, Inc. | 06/09/2000SE |
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Questions and answers
When was Euroimmun Anti-Desmoglein 1 Elisa (Igg), Euroimmun Anti-Desmoglein 3 Elisa (Igg) cleared by the FDA?
Euroimmun Anti-Desmoglein 1 Elisa (Igg), Euroimmun Anti-Desmoglein 3 Elisa (Igg) (K091969) received a 510(k) decision of Substantially Equivalent on September 2, 2010, 428 days after the submission was received.
What is the product code of K091969?
The FDA product code is NBO – Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3), a Class II (moderate risk) device regulated under 21 CFR 866.5660.