The following data is part of a premarket notification filed by Euroimmun Us, Inc. with the FDA for Euroimmun Ifa: Crithidia Luciliae (anti-dsdna) Europattern.
| Device ID | K172244 |
| 510k Number | K172244 |
| Device Name: | EUROIMMUN IFA: Crithidia Luciliae (anti-dsDNA) EUROPattern |
| Classification | Anti-dna Indirect Immunofluorescent Solid Phase |
| 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 | KTL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-26 |
| Decision Date | 2018-04-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049016107064 | K172244 | 000 |
| 04049016107033 | K172244 | 000 |
| 04049016107026 | K172244 | 000 |
| 04049016107057 | K172244 | 000 |