Cleared Traditional

SENTINEL LITHIUM ASSAY

K070987 · SENTINEL CH. SpA · Toxicology
Aug 2007
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K070987 is an FDA 510(k) clearance for the SENTINEL LITHIUM ASSAY, a Assay, Porphyrin, Spectrophotometry, Lithium (Class II — Special Controls, product code NDW), submitted by SENTINEL CH. SpA (Milano, IT). The FDA issued a Cleared decision on August 2, 2007, 118 days after receiving the submission on April 6, 2007. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3560.

Submission Details

510(k) Number K070987 FDA.gov
FDA Decision Cleared SESE
Date Received April 06, 2007
Decision Date August 02, 2007
Days to Decision 118 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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