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FDA 510(k), K043529, ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE
FDA 510(k), K043529, ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE
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510(K) Number: K043529
Device Name: ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE
Manufacturer: ROCHE DIAGNOSTICS CORP.
Device Classification Name: calculator, drug dose
Regulation Number: 868.1890
Classification Product Code: NDC
Date Received: 12/21/2004
Decision Date: 04/08/2005
Regulation Medical Specialty: Anesthesiology
Device Name: ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE
Manufacturer: ROCHE DIAGNOSTICS CORP.
Device Classification Name: calculator, drug dose
Regulation Number: 868.1890
Classification Product Code: NDC
Date Received: 12/21/2004
Decision Date: 04/08/2005
Regulation Medical Specialty: Anesthesiology
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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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