GENE-TRAK CAMPYLOBACTER ASSAY— 510(k) K863270

Name: FDA 510(k) clearance K863270
Creator: U.S. Food and Drug Administration
Published: 1987-08-31

Substantially Equivalent

Integrated Genetics

FDA 510(k) clearance K863270 for GENE-TRAK CAMPYLOBACTER ASSAY, Substantially Equivalent on 1987-08-31. Applicant: Integrated Genetics. Device class: 1.

Clearance details

Applicant: Integrated Genetics
Product code: Code LQO
Device class: Class 1
Regulation: 21 CFR 866.3110
Advisory panel: Microbiology
Date received: 1986-08-25
Decision date: 1987-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Framingham, MA, US

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