510(k) K113243
K113243 is an FDA 510(k) premarket notification submitted by Eps Bio Technology Corp. for the device "EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM". The FDA issued a decision of Substantially Equivalent on Mar 28, 2012. The device falls under product code LFR (Glucose Dehydrogenase, Glucose), a Class II device regulated under 21 CFR 862.1345. Eps Bio Technology Corp. has 24 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 28, 2012
- Date Received
- Nov 2, 2011
- 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
- 510(k)