AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE— 510(k) K895465

Name: FDA 510(k) clearance K895465
Creator: U.S. Food and Drug Administration
Published: 1989-12-27

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K895465 for AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE, Substantially Equivalent on 1989-12-27. Applicant: Baxter Healthcare Corp. Device class: 2.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code JIH
Device class: Class 2
Regulation: 21 CFR 862.3560
Advisory panel: Clinical Toxicology
Date received: 1989-09-11
Decision date: 1989-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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