Skip to content

Lytening 6 Sodium/Potassium/Ionized Calcium Analyz

by Amdev, Inc. 510(k)

Active United States

510(k) K884731

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK884731 Date3 Feb 1989ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 11 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JFP
Device Class
Class II
Regulation
21 CFR Part 862.1145
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Other devices from Amdev, Inc.

  • Lytening 2

    Class II

  • Lytening Tm 6/R

    Class II

  • Apec Glucose Analyzer

    Class II

  • Lytening 5

    Class II

  • Lytening 1

    Class II