Cleared Traditional

KARYOTEC 100

K872755 · Amcor Electronics, Ltd. · Pathology
Sep 1987
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K872755 is an FDA 510(k) clearance for the KARYOTEC 100, a Analyzer, Chromosome, Automated (Class II — Special Controls, product code LNJ), submitted by Amcor Electronics, Ltd. (Herzeliya, IL). The FDA issued a Cleared decision on September 1, 1987, 50 days after receiving the submission on July 13, 1987. This device falls under the Pathology review panel. Regulated under 21 CFR 864.5260.

Submission Details

510(k) Number K872755 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 1987
Decision Date September 01, 1987
Days to Decision 50 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

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