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Full 510(k) Record – i-STAT CHEM8+ & epoc Blood Analysis Systems (K191360, K200107)
Full 510(k) Record – i-STAT CHEM8+ & epoc Blood Analysis Systems (K191360, K200107)
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510(K) Number: K191360
Device Name: i-STAT CHEM8+ cartridge with the i-STAT 1 System
Manufacturer: Abbott Point of Care, Inc.
Device Classification Name: Electrode, Ion Specific, Calcium
Regulation Number: 862.1145
Classification Product Code: JFP
Date Received: 05/21/2019
Decision Date: 02/14/2020
Regulation Medical Specialty: Clinical Chemistry
Request Contents: Full 510(k) record of K191360 i-STAT CHEM8+ cartridge with the i-STAT 1 System and K200107 epoc Blood Analysis System.
Device Name: i-STAT CHEM8+ cartridge with the i-STAT 1 System
Manufacturer: Abbott Point of Care, Inc.
Device Classification Name: Electrode, Ion Specific, Calcium
Regulation Number: 862.1145
Classification Product Code: JFP
Date Received: 05/21/2019
Decision Date: 02/14/2020
Regulation Medical Specialty: Clinical Chemistry
Request Contents: Full 510(k) record of K191360 i-STAT CHEM8+ cartridge with the i-STAT 1 System and K200107 epoc Blood Analysis System.
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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