510(k) K974426
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