The following data is part of a premarket notification filed by Infrared Laboratory Systems, Llc (dba Synermed) with the FDA for Synermed Opiate Enzyme Immunoassay.
| Device ID | K172416 |
| 510k Number | K172416 |
| Device Name: | Synermed Opiate Enzyme Immunoassay |
| Classification | Enzyme Immunoassay, Opiates |
| 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 | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-10 |
| Decision Date | 2018-04-19 |
| Summary: | summary |