510(k) K151639
K151639 is an FDA 510(k) premarket notification submitted by Sendx Medical, Inc. for the device "ABL80 FLEX and ABL80 FLEX CO-OX". The FDA issued a decision of Substantially Equivalent on December 7, 2015. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Sendx Medical, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 7, 2015
- Date Received
- June 18, 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