ST AIA-PACK CA 125 ENZYME IMMUNOASSAY— 510(k) K023891

Name: FDA 510(k) clearance K023891
Creator: U.S. Food and Drug Administration
Published: 2002-12-06

Substantially Equivalent

Tosoh Medics, Inc.

FDA 510(k) clearance K023891 for ST AIA-PACK CA 125 ENZYME IMMUNOASSAY, Substantially Equivalent on 2002-12-06. Applicant: Tosoh Medics, Inc.. Device class: 2.

Clearance details

Applicant: Tosoh Medics, Inc.
Product code: Code LTK
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 2002-11-22
Decision date: 2002-12-06
Decision: Substantially Equivalent
Clearance type: Special
Location: South San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

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