K131444 is an FDA 510(k) clearance for the UA-CELLULAR COMPLETE. This device is classified as a Urinalysis Controls (assayed And Unassayed) (Class I - General Controls, product code JJW).
Submitted by Streck (La Vista, US). The FDA issued a Cleared decision on January 29, 2014, 254 days after receiving the submission on May 20, 2013.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K131444 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 2013 |
| Decision Date | January 29, 2014 |
| Days to Decision | 254 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JJW — Urinalysis Controls (assayed And Unassayed) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1660 |