COMINED STANDARD SOLUTION— 510(k) K130100

Name: FDA 510(k) clearance K130100
Creator: U.S. Food and Drug Administration
Published: 2013-04-18

Substantially Equivalent

Mesa Laboratories, Inc.

FDA 510(k) clearance K130100 for COMINED STANDARD SOLUTION, Substantially Equivalent on 2013-04-18. Applicant: Mesa Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Mesa Laboratories, Inc.
Product code: Code FKH
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 2013-01-15
Decision date: 2013-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

Download summary PDF View on FDA.gov ↗

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