SERIM DIALYSATE MONITOR TEST STRIP— 510(k) K043031

Name: FDA 510(k) clearance K043031
Creator: U.S. Food and Drug Administration
Published: 2005-06-13

Substantially Equivalent

Serim Research Corp.

FDA 510(k) clearance K043031 for SERIM DIALYSATE MONITOR TEST STRIP, Substantially Equivalent on 2005-06-13. Applicant: Serim Research Corp.. Device class: 2.

Clearance details

Applicant: Serim Research Corp.
Product code: Code NTZ
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 2004-11-03
Decision date: 2005-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

Download summary PDF View on FDA.gov ↗

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