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FDA 510(k), K092849, BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER
FDA 510(k), K092849, BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER
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510(K) Number: K092849
Device Name: BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER
Manufacturer: EPOCAL, INC.
Device Classification Name: electrode, ion specific, potassium
Regulation Number: 862.1600
Classification Product Code: CEM
Date Received: 09/16/2009
Decision Date: 03/30/2010
Regulation Medical Specialty: Clinical Chemistry
Device Name: BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER
Manufacturer: EPOCAL, INC.
Device Classification Name: electrode, ion specific, potassium
Regulation Number: 862.1600
Classification Product Code: CEM
Date Received: 09/16/2009
Decision Date: 03/30/2010
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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