Cleared Traditional

ADVIA IMS LITHIUM ASSAY

K050374 · Bayer Healthcare, LLC · Chemistry
Jun 2005
Decision
121d
Days
Class 2
Risk

About This 510(k) Submission

K050374 is an FDA 510(k) clearance for the ADVIA IMS LITHIUM ASSAY, a Assay, Porphyrin, Spectrophotometry, Lithium (Class II — Special Controls, product code NDW), submitted by Bayer Healthcare, LLC (New York, US). The FDA issued a Cleared decision on June 15, 2005, 121 days after receiving the submission on February 14, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3560.

Submission Details

510(k) Number K050374 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 2005
Decision Date June 15, 2005
Days to Decision 121 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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