URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C— 510(k) K880584

Name: FDA 510(k) clearance K880584
Creator: U.S. Food and Drug Administration
Published: 1988-05-31

Substantially Equivalent

Mach Diag. C/O Wichita State University

FDA 510(k) clearance K880584 for URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C, Substantially Equivalent on 1988-05-31. Applicant: Mach Diag. C/O Wichita State University. Device class: 1.

Clearance details

Applicant: Mach Diag. C/O Wichita State University
Product code: Code CDM
Device class: Class 1
Regulation: 21 CFR 862.1785
Advisory panel: Clinical Chemistry
Date received: 1988-02-10
Decision date: 1988-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wichita, KS, US

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