Cleared Traditional

LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901

K003583 · Trace America, Inc. · Chemistry
Jan 2001
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K003583 is an FDA 510(k) clearance for the LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901, a Assay, Porphyrin, Spectrophotometry, Lithium (Class II — Special Controls, product code NDW), submitted by Trace America, Inc. (Arlington, US). The FDA issued a Cleared decision on January 17, 2001, 58 days after receiving the submission on November 20, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3560.

Submission Details

510(k) Number K003583 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 2000
Decision Date January 17, 2001
Days to Decision 58 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code NDW — Assay, Porphyrin, Spectrophotometry, Lithium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3560

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