LYTENING 6 SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ— 510(k) K884731

Name: FDA 510(k) clearance K884731
Creator: U.S. Food and Drug Administration
Published: 1989-02-03

Substantially Equivalent

Amdev, Inc.

FDA 510(k) clearance K884731 for LYTENING 6 SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ, Substantially Equivalent on 1989-02-03. Applicant: Amdev, Inc.. Device class: 2.

Clearance details

Applicant: Amdev, Inc.
Product code: Code JFP
Device class: Class 2
Regulation: 21 CFR 862.1145
Advisory panel: Clinical Chemistry
Date received: 1988-11-10
Decision date: 1989-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danvers, MA, US

Download summary PDF View on FDA.gov ↗

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