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FDA 510(k), K163342, i-STAT Hematocrit test with i-STAT Alinity System
FDA 510(k), K163342, i-STAT Hematocrit test with i-STAT Alinity System
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510(K) Number: K163342
Device Name: i-STAT Hematocrit test with i-STAT Alinity System
Manufacturer: Abbott Laboratories
Device Classification Name: device, hematocrit measuring
Regulation Number: 864.6400
Classification Product Code: JPI
Date Received: 11/29/2016
Decision Date: 08/22/2017
Regulation Medical Specialty: Hematology
Device Name: i-STAT Hematocrit test with i-STAT Alinity System
Manufacturer: Abbott Laboratories
Device Classification Name: device, hematocrit measuring
Regulation Number: 864.6400
Classification Product Code: JPI
Date Received: 11/29/2016
Decision Date: 08/22/2017
Regulation Medical Specialty: Hematology
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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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