Cleared Special

ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY

K020806 · Bayer Corp. · Immunology
Mar 2002
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K020806 is an FDA 510(k) clearance for the ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY, a Kit, Test,alpha-fetoprotein For Testicular Cancer (Class II — Special Controls, product code LOJ), submitted by Bayer Corp. (Medfield, US). The FDA issued a Cleared decision on March 27, 2002, 15 days after receiving the submission on March 12, 2002. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K020806 FDA.gov
FDA Decision Cleared SESE
Date Received March 12, 2002
Decision Date March 27, 2002
Days to Decision 15 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LOJ — Kit, Test,alpha-fetoprotein For Testicular Cancer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.6010

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