Cleared Special

ST AIA-PACK CA 125 ENZYME IMMUNOASSAY

K023891 · Tosoh Medics, Inc. · Immunology
Dec 2002
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K023891 is an FDA 510(k) clearance for the ST AIA-PACK CA 125 ENZYME IMMUNOASSAY, a Test, Epithelial Ovarian Tumor-associated Antigen (ca125) (Class II — Special Controls, product code LTK), submitted by Tosoh Medics, Inc. (South San Francisco, US). The FDA issued a Cleared decision on December 6, 2002, 14 days after receiving the submission on November 22, 2002. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K023891 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 2002
Decision Date December 06, 2002
Days to Decision 14 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LTK — Test, Epithelial Ovarian Tumor-associated Antigen (ca125)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.6010

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