Cleared Traditional

'TDXFLX ANALYZER

K904226 · Abbott Laboratories · Chemistry
Oct 1990
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K904226 is an FDA 510(k) clearance for the 'TDXFLX ANALYZER, a Fluorescent Immunoassay Gentamicin (Class II — Special Controls, product code LCQ), submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 29, 1990, 46 days after receiving the submission on September 13, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3450.

Submission Details

510(k) Number K904226 FDA.gov
FDA Decision Cleared SESE
Date Received September 13, 1990
Decision Date October 29, 1990
Days to Decision 46 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code LCQ — Fluorescent Immunoassay Gentamicin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3450

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