The following data is part of a premarket notification filed by Euroimmun Us Inc with the FDA for Euroimmun Anti-m2-3e Elisa (igg).
| Device ID | K092736 |
| 510k Number | K092736 |
| Device Name: | EUROIMMUN ANTI-M2-3E ELISA (IGG) |
| Classification | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | EUROIMMUN US INC 95 WASHINGTON ST Morristown, NJ 07960 |
| Contact | Kathryn Kohl |
| Correspondent | Kathryn Kohl EUROIMMUN US INC 95 WASHINGTON ST Morristown, NJ 07960 |
| Product Code | DBM |
| CFR Regulation Number | 866.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-04 |
| Decision Date | 2010-09-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049016027157 | K092736 | 000 |