Cleared Traditional

8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM

K992662 · Bayer Corp. · Chemistry
Feb 2000
Decision
190d
Days
Class 1
Risk

About This 510(k) Submission

K992662 is an FDA 510(k) clearance for the 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM, a Apolipoproteins (Class I — General Controls, product code MSJ), submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on February 15, 2000, 190 days after receiving the submission on August 9, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K992662 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 1999
Decision Date February 15, 2000
Days to Decision 190 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code MSJ — Apolipoproteins
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

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