The following data is part of a premarket notification filed by Jas Diagnostics, Inc. with the FDA for Xl-200 Clinical Chemistry Analyzer, Jas Glucose Reagent, Ise Reagent Pack.
| Device ID | K130915 |
| 510k Number | K130915 |
| Device Name: | XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | JAS Diagnostics, Inc. 14100 N.W. 57th Court Miami Lakes, FL 33014 |
| Contact | David H Johnston |
| Correspondent | David H Johnston JAS Diagnostics, Inc. 14100 N.W. 57th Court Miami Lakes, FL 33014 |
| Product Code | JJE |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CFR |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JGS |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-02 |
| Decision Date | 2014-05-15 |
| Summary: | summary |