510(k) K974426

POTENCY TEST STRIPS, INDICATOR TEST STRIPS by Reprocessing Products Corp — Product Code LIF

K974426 is an FDA 510(k) premarket notification submitted by Reprocessing Products Corp for the device "POTENCY TEST STRIPS, INDICATOR TEST STRIPS". The FDA issued a decision of Substantially Equivalent on February 10, 1999. The device falls under product code LIF (Dialyzer Reprocessing System), 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
February 10, 1999
Date Received
October 27, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer Reprocessing System
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type