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510(k) K191298

i-STAT CHEM8+ cartridge with the i-STAT 1 System by Abbott Point of Care, Inc. — Product Code JFL

K191298 is an FDA 510(k) premarket notification submitted by Abbott Point of Care, Inc. for the device "i-STAT CHEM8+ cartridge with the i-STAT 1 System". The FDA issued a decision of Substantially Equivalent on February 7, 2020. The device falls under product code JFL (Ph Rate Measurement, Carbon-Dioxide), a Class II device regulated under 21 CFR 862.1160. Abbott Point of Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2020
Date Received
May 14, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ph Rate Measurement, Carbon-Dioxide
Device Class
Class II
Regulation Number
862.1160
Review Panel
CH
Submission Type

Other clearances by Abbott Point of Care, Inc.

  • K261039 — i-STAT Crea cartridge with the i-STAT 1 System (June 26, 2026)
  • K253051 — i-STAT hs-TnI cartridge with the i-STAT Alinity System (June 11, 2026)
  • K244014 — i-STAT CG4+ cartridge with the i-STAT 1 System (May 2, 2025)
  • K240984 — i-STAT hs-TnI cartridge with the i-STAT 1 System (January 3, 2025)
  • K234143 — i-STAT TBI Cartridge with the i-STAT Alinity System (March 27, 2024)
  • K230275 — i-STAT CG8+ cartridge with the i-STAT 1 System (October 27, 2023)
  • K230285 — i-STAT CG8+ cartridge with the i-STAT 1 System (October 27, 2023)
  • K230300 — i-STAT CG8+ cartridge with the i-STAT 1 System (October 27, 2023)
  • K223857 — i-STAT G3+ cartridge with the i-STAT 1 System (September 15, 2023)
  • K223755 — i-STAT G cartridge with the i-STAT 1 System (September 11, 2023)

Other clearances for product code JFL

  • K040975 — GENCHEM CO2 ACID REAGENT (December 27, 2004)
  • K014034 — MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO) (December 18, 2001)
  • K963541 — SIGMA DIAGNOSTICS CO2 ACID REAGENT (October 24, 1996)
  • K963538 — SIGMA DIAGNOSTICS CO2ALKALINE BUFFER (October 11, 1996)
  • K963540 — SIGMA DIAGNOSTICS ELECTROLYTE BUFFER (September 27, 1996)
  • K963005 — NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE) (August 23, 1996)
  • K933696 — SIGMA ELECTROLYTE REFERENCE REAGENT (January 3, 1994)
  • K933691 — SIGMA CO2 ALKALINE BUFFER REAGENT (December 17, 1993)
  • K933692 — SIGMA CO2 ACID REAGENT (December 9, 1993)
  • K933695 — SIGMA ELECTROLYTE BUFFER (October 22, 1993)

FDA data resources