510(k) K101750
K101750 is an FDA 510(k) premarket notification submitted by Reprocessing Products Corp for the device "RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104". The FDA issued a decision of Substantially Equivalent on January 7, 2011. The device falls under product code MNV (Strip, Dialysate Ph Indicator), a Class II device regulated under 21 CFR 876.5820. Reprocessing Products Corp has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 7, 2011
- Date Received
- June 22, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Strip, Dialysate Ph Indicator
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type