K170091 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 February 9, 2017, 30 days after receiving the submission on January 10, 2017.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K170091 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 10, 2017 |
| Decision Date | February 09, 2017 |
| Days to Decision | 30 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 |