510(k) K101750

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 by Reprocessing Products Corp — Product Code MNV

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