Cleared Special

K023894 - ST AIA-PACK AFP ENZYME IMMUNOASSAY
(FDA 510(k) Clearance)

K023894 · Tosoh Medics, Inc. · Immunology

Dec 2002

Decision

25d

Days

Class 2

Risk

K023894 is an FDA 510(k) clearance for the ST AIA-PACK AFP ENZYME IMMUNOASSAY. This device is classified as a Kit, Test,alpha-fetoprotein For Testicular Cancer (Class II — Special Controls, product code LOJ).

Submitted by Tosoh Medics, Inc. (South San Francisco, US). The FDA issued a Cleared decision on December 17, 2002, 25 days after receiving the submission on November 22, 2002.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number	K023894 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 22, 2002
Decision Date	December 17, 2002
Days to Decision	25 days
Submission Type	Special
Review Panel	Immunology (IM)
Summary	Summary PDF