510(k) K153692
K153692 is an FDA 510(k) premarket notification submitted by Infrared Laboratory Systems, LLC (Dba Synermed) for the device "Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer". The FDA issued a decision of Substantially Equivalent on June 24, 2016. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Infrared Laboratory Systems, LLC (Dba Synermed) has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 24, 2016
- Date Received
- December 23, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Glucose Oxidase, Glucose
- Device Class
- Class II
- Regulation Number
- 862.1345
- Review Panel
- CH
- Submission Type