The following data is part of a premarket notification filed by Infrared Laboratory Systems, Llc (dba Synermed) with the FDA for Synermed Ise Reagents.
| Device ID | K181201 |
| 510k Number | K181201 |
| Device Name: | Synermed ISE Reagents |
| Classification | Electrode, Ion Specific, Sodium |
| 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 | JGS |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-07 |
| Decision Date | 2018-07-10 |
| Summary: | summary |