FDA 510(k), K061597, EPOC BLOOD ANALYSIS SYSTEM
FDA 510(k), K061597, EPOC BLOOD ANALYSIS SYSTEM
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510(K) Number: K061597
Device Name: EPOC BLOOD ANALYSIS SYSTEM
Manufacturer: EPOCAL, INC.
Device Classification Name: Electrode, Ion Specific, Sodium
Regulation Number: 862.1665
Classification Product Code: JGS
Date Received: 06/08/2006
Decision Date: 09/27/2006
Regulation Medical Specialty: Clinical Chemistry
Device Name: EPOC BLOOD ANALYSIS SYSTEM
Manufacturer: EPOCAL, INC.
Device Classification Name: Electrode, Ion Specific, Sodium
Regulation Number: 862.1665
Classification Product Code: JGS
Date Received: 06/08/2006
Decision Date: 09/27/2006
Regulation Medical Specialty: Clinical Chemistry
- 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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