Cleared Traditional

FISHVIEW

K050236 · Applied Spectral Imaging , Ltd. · Pathology
Jun 2005
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K050236 is an FDA 510(k) clearance for the FISHVIEW, a Analyzer, Chromosome, Automated (Class II — Special Controls, product code LNJ), submitted by Applied Spectral Imaging , Ltd. (Haifa, IL). The FDA issued a Cleared decision on June 27, 2005, 147 days after receiving the submission on January 31, 2005. This device falls under the Pathology review panel. Regulated under 21 CFR 864.5260.

Submission Details

510(k) Number K050236 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2005
Decision Date June 27, 2005
Days to Decision 147 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF

Device Classification

Product Code LNJ — Analyzer, Chromosome, Automated
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5260