QUIX RAPID E. COLI O157 STRIP TEST— 510(k) K972156

Name: FDA 510(k) clearance K972156
Creator: U.S. Food and Drug Administration
Published: 1997-10-16

Substantially Equivalent

Guardian Scientific, Corp.

FDA 510(k) clearance K972156 for QUIX RAPID E. COLI O157 STRIP TEST, Substantially Equivalent on 1997-10-16. Applicant: Guardian Scientific, Corp.. Device class: 1.

Clearance details

Applicant: Guardian Scientific, Corp.
Product code: Code GMZ
Device class: Class 1
Regulation: 21 CFR 866.3255
Advisory panel: Microbiology
Date received: 1997-06-09
Decision date: 1997-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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