510(k) K102316
K102316 is an FDA 510(k) premarket notification submitted by Broadmaster Biotech Corporation for the device "GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on Oct 7, 2011. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Broadmaster Biotech Corporation has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 7, 2011
- Date Received
- Aug 16, 2010
- 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
- 510(k)