The following data is part of a premarket notification filed by Infrared Laboratory Systems, Llc (dba Synermed) with the FDA for Synermed Glucose Reagent, Synermed Ir-1200 Chemistry Analyzer.
| Device ID | K153692 |
| 510k Number | K153692 |
| Device Name: | Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer |
| Classification | Glucose Oxidase, Glucose |
| Applicant | INFRARED LABORATORY SYSTEMS, LLC (DBA SYNERMED) 17408 TILLER COURT SUITE 1900 Westfield, IN 40674 |
| Contact | Julie Paschal |
| Correspondent | Julie Paschal INFRARED LABORATORY SYSTEMS, LLC (DBA SYNERMED) 17408 TILLER COURT SUITE 1900 Westfield, IN 40674 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-23 |
| Decision Date | 2016-06-24 |
| Summary: | summary |