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510(k) K904726

LYTENING TM 6/R by Amdev, Inc. — Product Code JFP

K904726 is an FDA 510(k) premarket notification submitted by Amdev, Inc. for the device "LYTENING TM 6/R". The FDA issued a decision of Substantially Equivalent on December 18, 1990. The device falls under product code JFP (Electrode, Ion Specific, Calcium), a Class II device regulated under 21 CFR 862.1145. Amdev, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1990
Date Received
October 17, 1990
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 Amdev, Inc.

  • K890524 — APEC GLUCOSE ANALYZER (March 15, 1989)
  • K884731 — LYTENING 6 SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ (February 3, 1989)
  • K880917 — LYTENING 5 (May 27, 1988)
  • K863521 — LYTENING 2 (November 5, 1986)
  • K853832 — LYTENING 1 (October 4, 1985)

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)
  • K943091 — EASY LYTE CALCIUM ANALYZER (January 17, 1995)

FDA data resources