SERIM BLOOD LEAK TEST STRIP-2— 510(k) K012115

Name: FDA 510(k) clearance K012115
Creator: U.S. Food and Drug Administration
Published: 2001-11-30

Substantially Equivalent

Serim Research Corp.

FDA 510(k) clearance K012115 for SERIM BLOOD LEAK TEST STRIP-2, Substantially Equivalent on 2001-11-30. Applicant: Serim Research Corp.. Device class: 2.

Clearance details

Applicant: Serim Research Corp.
Product code: Code FJD
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 2001-07-06
Decision date: 2001-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

Download summary PDF View on FDA.gov ↗

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