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FDA 510(k), K964264, HIGH RANGE PEROXIDE TEST STRIP
FDA 510(k), K964264, HIGH RANGE PEROXIDE TEST STRIP
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510(K) Number: K964264
Device Name: HIGH RANGE PEROXIDE TEST STRIP
Manufacturer: WEN H WU
Device Classification Name: System, Dialysate Delivery, Single Patient
Regulation Number: FKP
Classification Product Code: 10/25/1996
Date Received: 06/16/1997
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: HIGH RANGE PEROXIDE TEST STRIP
Manufacturer: WEN H WU
Device Classification Name: System, Dialysate Delivery, Single Patient
Regulation Number: FKP
Classification Product Code: 10/25/1996
Date Received: 06/16/1997
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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