K130915 is an FDA 510(k) clearance for the XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK. This device is classified as a Analyzer, Chemistry (photometric, Discrete), For Clinical Use (Class I - General Controls, product code JJE).
Submitted by Jas Diagnostics, Inc. (Miami Lakes, US). The FDA issued a Cleared decision on May 15, 2014, 408 days after receiving the submission on April 2, 2013.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2160.
| 510(k) Number | K130915 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 2013 |
| Decision Date | May 15, 2014 |
| Days to Decision | 408 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JJE — Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2160 |