510(k) K181201
K181201 is an FDA 510(k) premarket notification submitted by Infrared Laboratory Systems, LLC (Dba Synermed) for the device "Synermed ISE Reagents". The FDA issued a decision of Substantially Equivalent on July 10, 2018. The device falls under product code JGS (Electrode, Ion Specific, Sodium), a Class II device regulated under 21 CFR 862.1665. Infrared Laboratory Systems, LLC (Dba Synermed) has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 10, 2018
- Date Received
- May 7, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Ion Specific, Sodium
- Device Class
- Class II
- Regulation Number
- 862.1665
- Review Panel
- CH
- Submission Type