510(k) K142689
K142689 is an FDA 510(k) premarket notification submitted by Apex BioTechnology Corp. for the device "GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System". The FDA issued a decision of Substantially Equivalent on August 6, 2015. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Apex BioTechnology Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 6, 2015
- Date Received
- September 22, 2014
- Clearance Type
- Special
- 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