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FDA 510(k), K120921, CLEVER CHOICE
FDA 510(k), K120921, CLEVER CHOICE
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510(K) Number: K120921
Device Name: CLEVER CHOICE
Manufacturer: SIMPLE DIAGNOSTICS, INC.
Device Classification Name: glucose oxidase, glucose
Regulation Number: 862.1345
Classification Product Code: CGA
Date Received: 03/27/2012
Decision Date: 08/21/2012
Regulation Medical Specialty: Clinical Chemistry
Device Name: CLEVER CHOICE
Manufacturer: SIMPLE DIAGNOSTICS, INC.
Device Classification Name: glucose oxidase, glucose
Regulation Number: 862.1345
Classification Product Code: CGA
Date Received: 03/27/2012
Decision Date: 08/21/2012
Regulation Medical Specialty: Clinical Chemistry
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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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