Cleared Traditional

BANDVIEW SYSTEM

K012103 · Applied Spectral Imaging , Ltd. · Pathology
Sep 2001
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K012103 is an FDA 510(k) clearance for the BANDVIEW SYSTEM, a Analyzer, Chromosome, Automated (Class II — Special Controls, product code LNJ), submitted by Applied Spectral Imaging , Ltd. (Ra'Ananna 43373, IL). The FDA issued a Cleared decision on September 14, 2001, 71 days after receiving the submission on July 5, 2001. This device falls under the Pathology review panel. Regulated under 21 CFR 864.5260.

Submission Details

510(k) Number K012103 FDA.gov
FDA Decision Cleared SESE
Date Received July 05, 2001
Decision Date September 14, 2001
Days to Decision 71 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