ELECSYSCA 15-3 II ASSAY— 510(k) K010588

Name: FDA 510(k) clearance K010588
Creator: U.S. Food and Drug Administration
Published: 2001-03-28

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K010588 for ELECSYSCA 15-3 II ASSAY, Substantially Equivalent on 2001-03-28. Applicant: Roche Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code MOI
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 2001-02-27
Decision date: 2001-03-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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