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FDA 510(k), K153357, i-STAT Alinity System with i-STAT Sodium test
FDA 510(k), K153357, i-STAT Alinity System with i-STAT Sodium test
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510(K) Number: K153357
Device Name: i-STAT Alinity System with i-STAT Sodium test
Manufacturer: ABBOTT POINT OF CARE INC.
Device Classification Name: electrode, ion specific, sodium
Regulation Number: 862.1665
Classification Product Code: JGS
Date Received: 11/20/2015
Decision Date: 07/08/2016
Regulation Medical Specialty: Clinical Chemistry
Device Name: i-STAT Alinity System with i-STAT Sodium test
Manufacturer: ABBOTT POINT OF CARE INC.
Device Classification Name: electrode, ion specific, sodium
Regulation Number: 862.1665
Classification Product Code: JGS
Date Received: 11/20/2015
Decision Date: 07/08/2016
Regulation Medical Specialty: Clinical Chemistry
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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