SERIM LEUKOCYTE ESTERASE TEST STRIPS— 510(k) K000578

Name: FDA 510(k) clearance K000578
Creator: U.S. Food and Drug Administration
Published: 2000-05-05

Substantially Equivalent

Serim Research Corp.

FDA 510(k) clearance K000578 for SERIM LEUKOCYTE ESTERASE TEST STRIPS, Substantially Equivalent on 2000-05-05. Applicant: Serim Research Corp.. Device class: 1.

Clearance details

Applicant: Serim Research Corp.
Product code: Code LJX
Device class: Class 1
Regulation: 21 CFR 864.7675
Advisory panel: Hematology
Date received: 2000-02-22
Decision date: 2000-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

Download summary PDF View on FDA.gov ↗

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