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510(k) K191360

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2020
Date Received
May 21, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Calcium
Device Class
Class II
Regulation Number
862.1145
Review Panel
CH
Submission Type

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  • K972673 — AVL 9181 ELECTROLYTE ANALYZER (August 20, 1997)
  • K963694 — EASYLYTE CALCIUM/CHLORIDE ANALYZER (November 27, 1996)
  • K961458 — AVL 9180 ELECTROLYTE ANALYZER (June 12, 1996)
  • K960120 — STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS (March 11, 1996)
  • K943091 — EASY LYTE CALCIUM ANALYZER (January 17, 1995)
  • K943702 — AVL 988-4 ELECTROLYTE ANALYZER (September 9, 1994)