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510(k) K943091

EASY LYTE CALCIUM ANALYZER by Medica Corp. — Product Code JFP

K943091 is an FDA 510(k) premarket notification submitted by Medica Corp. for the device "EASY LYTE CALCIUM ANALYZER". The FDA issued a decision of Substantially Equivalent on January 17, 1995. The device falls under product code JFP (Electrode, Ion Specific, Calcium), a Class II device regulated under 21 CFR 862.1145. Medica Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1995
Date Received
June 28, 1994
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 Corp.

  • K123802 — EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT (March 1, 2013)
  • K120497 — EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL (May 14, 2012)
  • K111363 — PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL (December 6, 2011)
  • K111005 — ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL (November 15, 2011)
  • K112788 — EASTLYTE NA/K/CA/PH (October 20, 2011)
  • K101089 — EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR (July 13, 2011)
  • K101090 — EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS (May 20, 2011)
  • K110675 — EASYRA UREA NITROGEN AND CREATININE REAGENTS (April 21, 2011)
  • K101088 — EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT (April 4, 2011)
  • K100829 — EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBO (January 14, 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)
  • 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)
  • K943702 — AVL 988-4 ELECTROLYTE ANALYZER (September 9, 1994)

FDA data resources