HIGH RANGE PEROXIDE TEST STRIP— 510(k) K964264

Name: FDA 510(k) clearance K964264
Creator: U.S. Food and Drug Administration
Published: 1997-06-16

Substantially Equivalent

Integrated Biomedical Technology, Inc.

FDA 510(k) clearance K964264 for HIGH RANGE PEROXIDE TEST STRIP, Substantially Equivalent on 1997-06-16. Applicant: Integrated Biomedical Technology, Inc.. Device class: 2.

Clearance details

Applicant: Integrated Biomedical Technology, Inc.
Product code: Code FKP
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1996-10-25
Decision date: 1997-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

Download summary PDF View on FDA.gov ↗

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