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FDA 510(k), K191298, i-STAT CHEM8+ cartridge with the i-STAT 1 System
FDA 510(k), K191298, i-STAT CHEM8+ cartridge with the i-STAT 1 System
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$49.00 USD
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510(K) Number: K191298
Device Name: i-STAT CHEM8+ cartridge with the i-STAT 1 System
Manufacturer: Susan Tibedo
Device Classification Name: Ph Rate Measurement, Carbon-Dioxide
Regulation Number: JFL
Classification Product Code: KXA
Date Received: 05/14/2019
Decision Date: 02/07/2020
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
Device Name: i-STAT CHEM8+ cartridge with the i-STAT 1 System
Manufacturer: Susan Tibedo
Device Classification Name: Ph Rate Measurement, Carbon-Dioxide
Regulation Number: JFL
Classification Product Code: KXA
Date Received: 05/14/2019
Decision Date: 02/07/2020
Decision: Substantially Equivalent (SESE)
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
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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