MODIFICATION TO: INSTAREAD LITHIUM SYSTEM— 510(k) K050338

Name: FDA 510(k) clearance K050338
Creator: U.S. Food and Drug Administration
Published: 2005-03-04

Substantially Equivalent

Akers Biosciences, Inc.

FDA 510(k) clearance K050338 for MODIFICATION TO: INSTAREAD LITHIUM SYSTEM, Substantially Equivalent on 2005-03-04. Applicant: Akers Biosciences, Inc.. Device class: 2.

Clearance details

Applicant: Akers Biosciences, Inc.
Product code: Code JIH
Device class: Class 2
Regulation: 21 CFR 862.3560
Advisory panel: Clinical Toxicology
Date received: 2005-02-11
Decision date: 2005-03-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Thorofare, NJ, US

Download summary PDF View on FDA.gov ↗

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