Cleared Traditional

BAYER ADVIA IMS SYSTEM

K010201 · Bayer Corp. · Chemistry
Mar 2001
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K010201 is an FDA 510(k) clearance for the BAYER ADVIA IMS SYSTEM, a Immunoassay Method, Troponin Subunit (Class II — Special Controls, product code MMI), submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on March 29, 2001, 66 days after receiving the submission on January 22, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K010201 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 2001
Decision Date March 29, 2001
Days to Decision 66 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code MMI — Immunoassay Method, Troponin Subunit
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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