510(k) K172416
K172416 is an FDA 510(k) premarket notification submitted by Infrared Laboratory Systems, LLC (Dba Synermed) for the device "Synermed Opiate Enzyme Immunoassay". The FDA issued a decision of Substantially Equivalent on April 19, 2018. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Infrared Laboratory Systems, LLC (Dba Synermed) has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 19, 2018
- Date Received
- August 10, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Opiates
- Device Class
- Class II
- Regulation Number
- 862.3650
- Review Panel
- TX
- Submission Type