ELECSYS CA 125 II CALSET— 510(k) K003969

Name: FDA 510(k) clearance K003969
Creator: U.S. Food and Drug Administration
Published: 2001-01-12

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K003969 for ELECSYS CA 125 II CALSET, Substantially Equivalent on 2001-01-12. Applicant: Roche Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code JIS
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 2000-12-22
Decision date: 2001-01-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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