Cleared Traditional

ACLAIMS-IS

K912085 · W-Technology · Pathology
Oct 1991
Decision
171d
Days
Class 2
Risk

About This 510(k) Submission

K912085 is an FDA 510(k) clearance for the ACLAIMS-IS, a Analyzer, Chromosome, Automated (Class II — Special Controls, product code LNJ), submitted by W-Technology (Carmichael, US). The FDA issued a Cleared decision on October 31, 1991, 171 days after receiving the submission on May 13, 1991. This device falls under the Pathology review panel. Regulated under 21 CFR 864.5260.

Submission Details

510(k) Number K912085 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 1991
Decision Date October 31, 1991
Days to Decision 171 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Statement

Device Classification

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