Cleared Traditional

COBAS LITHIUM

K063684 · Roche Diagnostics Corp. · Toxicology
Mar 2008
Decision
465d
Days
Class 2
Risk

About This 510(k) Submission

K063684 is an FDA 510(k) clearance for the COBAS LITHIUM, a Assay, Porphyrin, Spectrophotometry, Lithium (Class II — Special Controls, product code NDW), submitted by Roche Diagnostics Corp. (Indianapolos, US). The FDA issued a Cleared decision on March 21, 2008, 465 days after receiving the submission on December 12, 2006. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3560.

Submission Details

510(k) Number K063684 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 2006
Decision Date March 21, 2008
Days to Decision 465 days
Submission Type Traditional
Review Panel Toxicology (TX)
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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