Cleared Traditional

GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO.

K902311 · Applied Imaging Corp. · Pathology

Aug 1990

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K902311 is an FDA 510(k) clearance for the GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO., a Analyzer, Chromosome, Automated (Class II — Special Controls, product code LNJ), submitted by Applied Imaging Corp. (Santa Clara, US). The FDA issued a Cleared decision on August 20, 1990, 89 days after receiving the submission on May 23, 1990. This device falls under the Pathology review panel. Regulated under 21 CFR 864.5260.

Submission Details

510(k) Number	K902311 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 23, 1990
Decision Date	August 20, 1990
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—