QWIKCHECK-BEADS— 510(k) K041600

Name: FDA 510(k) clearance K041600
Creator: U.S. Food and Drug Administration
Published: 2004-07-27

Substantially Equivalent

Medical Electronics Systems , Ltd.

FDA 510(k) clearance K041600 for QWIKCHECK-BEADS, Substantially Equivalent on 2004-07-27. Applicant: Medical Electronics Systems , Ltd.. Device class: 2.

Clearance details

Applicant: Medical Electronics Systems , Ltd.
Product code: Code NRF
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 2004-06-14
Decision date: 2004-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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