DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440— 510(k) K912666

Name: FDA 510(k) clearance K912666
Creator: U.S. Food and Drug Administration
Published: 1992-02-14

Substantially Equivalent

Dako Corp.

FDA 510(k) clearance K912666 for DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440, Substantially Equivalent on 1992-02-14. Applicant: Dako Corp.. Device class: 1.

Clearance details

Applicant: Dako Corp.
Product code: Product code LIQ
Device class: Class 1
Regulation: 21 CFR 866.3405
Advisory panel: Microbiology
Date received: 1991-06-18
Decision date: 1992-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denmark, DK

Download summary PDF View on FDA.gov ↗

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