E-Z CHEK BLOOD LEAK TEST STRIPS— 510(k) K123805

Name: FDA 510(k) clearance K123805
Creator: U.S. Food and Drug Administration
Published: 2013-03-20

Substantially Equivalent

Reprocessing Products Corp

FDA 510(k) clearance K123805 for E-Z CHEK BLOOD LEAK TEST STRIPS, Substantially Equivalent on 2013-03-20. Applicant: Reprocessing Products Corp. Device class: 2.

Clearance details

Applicant: Reprocessing Products Corp
Product code: Code FJD
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 2012-12-11
Decision date: 2013-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucson, AZ, US

Download summary PDF View on FDA.gov ↗

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