E-Z CHECK OZONE TEST STRIPS— 510(k) K132344

Name: FDA 510(k) clearance K132344
Creator: U.S. Food and Drug Administration
Published: 2014-02-25

Substantially Equivalent

Reprocessing Products Corporation (Rpc)

FDA 510(k) clearance K132344 for E-Z CHECK OZONE TEST STRIPS, Substantially Equivalent on 2014-02-25. Applicant: Reprocessing Products Corporation (Rpc). Device class: 2.

Clearance details

Applicant: Reprocessing Products Corporation (Rpc)
Product code: Code MSY
Device class: Class 2
Regulation: 21 CFR 876.5665
Advisory panel: Gastroenterology, Urology
Date received: 2013-07-29
Decision date: 2014-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucson, AZ, US

Download summary PDF View on FDA.gov ↗

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