The following data is part of a premarket notification filed by Euroimmun Us, Inc. with the FDA for Euroimmun Anti-tissue Transglutaminase Elisa (iga), Euroimmun Anti-tissue Transglutaminase Elisa (igg).
| Device ID | K183313 |
| 510k Number | K183313 |
| Device Name: | EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) |
| Classification | Autoantibodies, Endomysial(tissue Transglutaminase) |
| Applicant | Euroimmun US, Inc. 1 Bloomfield Avenue Mountain Lakes, NJ 07046 |
| Contact | Daniel Castellanos |
| Correspondent | Daniel Castellanos Euroimmun US, Inc. 1 Bloomfield Avenue Mountain Lakes, NJ 07046 |
| Product Code | MVM |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-29 |
| Decision Date | 2019-02-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049016027294 | K183313 | 000 |
| 04049016027287 | K183313 | 000 |