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 |