Home / 510(k) Clearances / K152327

510(k) K152327

EasyLyte Na/K/Cl/Ca Analyzer by Medica Corporation — Product Code JFP

K152327 is an FDA 510(k) premarket notification submitted by Medica Corporation for the device "EasyLyte Na/K/Cl/Ca Analyzer". The FDA issued a decision of Substantially Equivalent on December 1, 2016. The device falls under product code JFP (Electrode, Ion Specific, Calcium), a Class II device regulated under 21 CFR 862.1145. Medica Corporation has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2016
Date Received
August 18, 2015
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

Other clearances by Medica Corporation

  • K220328 — EasyStat 300 (July 26, 2024)
  • K220396 — EasyStat 300 (September 26, 2023)
  • K211559 — EasyStat 300 (January 27, 2023)
  • K130080 — EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CR (May 13, 2014)
  • K123586 — EASYRA CREATININE REAGENT (May 15, 2013)
  • K111036 — EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT (July 12, 2011)

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)
  • K191626 — Stat Profile Prime ES Comp Plus Analyzer System (August 16, 2019)
  • 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)

FDA data resources