510(k) K142089
K142089 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corporation for the device "ACCU-CHEK AVIVA EXPERT SYSTEM". The FDA issued a decision of Substantially Equivalent on December 17, 2014. The device falls under product code LFR (Glucose Dehydrogenase, Glucose), a Class II device regulated under 21 CFR 862.1345. Roche Diagnostics Corporation has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 2014
- Date Received
- August 1, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Glucose Dehydrogenase, Glucose
- Device Class
- Class II
- Regulation Number
- 862.1345
- Review Panel
- CH
- Submission Type