510(k) K113726
K113726 is an FDA 510(k) premarket notification submitted by Epocal, Inc. for the device "EPOC CHLORIDE TEST AND EPOC CREATININE TEST". The FDA issued a decision of Substantially Equivalent on October 5, 2012. The device falls under product code CGL (Electrode, Ion Based, Enzymatic, Creatinine), a Class II device regulated under 21 CFR 862.1225. Epocal, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 5, 2012
- Date Received
- December 19, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Ion Based, Enzymatic, Creatinine
- Device Class
- Class II
- Regulation Number
- 862.1225
- Review Panel
- CH
- Submission Type