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510(k) K191626

Stat Profile Prime ES Comp Plus Analyzer System by Nova Biomedical Corporation — Product Code JFP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2019
Date Received
June 18, 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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Other clearances for product code JFP

  • K230300 — i-STAT CG8+ cartridge with the i-STAT 1 System (October 27, 2023)
  • K191360 — i-STAT CHEM8+ cartridge with the i-STAT 1 System (February 14, 2020)
  • K152327 — EasyLyte Na/K/Cl/Ca Analyzer (December 1, 2016)
  • K984299 — AVL OPTI CRITICAL CARE ANALYZER (December 11, 1998)
  • 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)