ROTA-DAN RAPID ROTAVIRUS EIA KIT— 510(k) K951208

Name: FDA 510(k) clearance K951208
Creator: U.S. Food and Drug Administration
Published: 1996-02-14

Substantially Equivalent

Eldan Technologies, Ltd.

FDA 510(k) clearance K951208 for ROTA-DAN RAPID ROTAVIRUS EIA KIT, Substantially Equivalent on 1996-02-14. Applicant: Eldan Technologies, Ltd.. Device class: 1.

Clearance details

Applicant: Eldan Technologies, Ltd.
Product code: Code LIQ
Device class: Class 1
Regulation: 21 CFR 866.3405
Advisory panel: Microbiology
Date received: 1995-03-17
Decision date: 1996-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jerusalem, IL

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Data sourced from openFDA. This site is unofficial and independent of the FDA.