510(k) K143325
K143325 is an FDA 510(k) premarket notification submitted by Eiken Chemical Co., Ltd. for the device "OC-Light S FIT". The FDA issued a decision of Substantially Equivalent on August 20, 2015. The device falls under product code KHE (Reagent, Occult Blood), a Class II device regulated under 21 CFR 864.6550. Eiken Chemical Co., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 20, 2015
- Date Received
- November 20, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reagent, Occult Blood
- Device Class
- Class II
- Regulation Number
- 864.6550
- Review Panel
- HE
- Submission Type