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FDA 510(k), K002011, GLUTARTEST 1 REAGENT STRIP
FDA 510(k), K002011, GLUTARTEST 1 REAGENT STRIP
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510(K) Number: K002011
Device Name: GLUTARTEST 1 REAGENT STRIP
Manufacturer: WEN H WU
Device Classification Name: Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
Regulation Number: MSY
Classification Product Code: 07/03/2000
Date Received: 01/22/2001
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: GLUTARTEST 1 REAGENT STRIP
Manufacturer: WEN H WU
Device Classification Name: Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
Regulation Number: MSY
Classification Product Code: 07/03/2000
Date Received: 01/22/2001
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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