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FDA 510(k), K850431, EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL
FDA 510(k), K850431, EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL
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510(K) Number: K850431
Device Name: EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL
Manufacturer: PERRY G RUCKER
Device Classification Name: Reagent, Occult Blood
Regulation Number: KHE
Classification Product Code: 02/04/1985
Date Received: 06/17/1985
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Hematology
Device Name: EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL
Manufacturer: PERRY G RUCKER
Device Classification Name: Reagent, Occult Blood
Regulation Number: KHE
Classification Product Code: 02/04/1985
Date Received: 06/17/1985
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Hematology
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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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