Submission Details
| 510(k) Number | K172244 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern
Apr 2018
Decision
268d
Days
Class 2
Risk
About This 510(k) Submission
K172244 is an FDA 510(k) clearance for the EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern, 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 review panel. Regulated under 21 CFR 866.5100.
Device Classification
| Product Code | KTL — Anti-dna Indirect Immunofluorescent Solid Phase |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5100 |
Manufacturer
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