510(k) K113636
K113636 is an FDA 510(k) premarket notification submitted by Philosys Co., Ltd. for the device "BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)". The FDA issued a decision of Substantially Equivalent on Mar 8, 2013. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 8, 2013
- Date Received
- Dec 9, 2011
- 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)