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FDA 510(k), K021827, MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
FDA 510(k), K021827, MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
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510(K) Number: K021827
Device Name: MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
Manufacturer: ROCHE DIAGNOSTICS CORP.
Device Classification Name: System, Test, Blood Glucose, Over The Counter
Regulation Number: 862.1345
Classification Product Code: NBW
Date Received: 06/04/2002
Decision Date: 07/03/2002
Regulation Medical Specialty: Clinical Chemistry
Device Name: MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
Manufacturer: ROCHE DIAGNOSTICS CORP.
Device Classification Name: System, Test, Blood Glucose, Over The Counter
Regulation Number: 862.1345
Classification Product Code: NBW
Date Received: 06/04/2002
Decision Date: 07/03/2002
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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