RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104— 510(k) K101750

Name: FDA 510(k) clearance K101750
Creator: U.S. Food and Drug Administration
Published: 2011-01-07

Substantially Equivalent

Reprocessing Products Corp

FDA 510(k) clearance K101750 for RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104, Substantially Equivalent on 2011-01-07. Applicant: Reprocessing Products Corp. Device class: 2.

Clearance details

Applicant: Reprocessing Products Corp
Product code: Code MNV
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 2010-06-22
Decision date: 2011-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, MN, US

Download summary PDF View on FDA.gov ↗

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