K172244 is an FDA 510(k) clearance for the EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern. This device is classified as a Anti-dna Indirect Immunofluorescent Solid Phase (Class II - Special Controls, product code KTL).
Submitted by Euroimmun Us, Inc. (Mountain Lakes, US). The FDA issued a Cleared decision on April 20, 2018, 268 days after receiving the submission on July 26, 2017.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K172244 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 2017 |
| Decision Date | April 20, 2018 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | KTL - Anti-dna Indirect Immunofluorescent Solid Phase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |