Synermed Opiate Enzyme Immunoassay— 510(k) K172416
Substantially EquivalentInfrared Laboratory Systems, LLC (Dba Synermed)
FDA 510(k) clearance K172416 for Synermed Opiate Enzyme Immunoassay, Substantially Equivalent on 2018-04-19. Applicant: Infrared Laboratory Systems, LLC (Dba Synermed).
Clearance details
- Applicant
- Infrared Laboratory Systems, LLC (Dba Synermed)
- Product code
- Code DJG
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westfield, IN, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.