Cleared Traditional

K891767 - GENETIC SYSTEMS MICROPLATE READER
(FDA 510(k) Clearance)

K891767 · Genetic Systems Corp. · Chemistry

Jul 1989

Decision

123d

Days

Class 1

Risk

K891767 is an FDA 510(k) clearance for the GENETIC SYSTEMS MICROPLATE READER, a Colorimeter, Photometer, Spectrophotometer For Clinical Use (Class I — General Controls, product code JJQ), submitted by Genetic Systems Corp. (Seattle, US). The FDA issued a Cleared decision on July 25, 1989, 123 days after receiving the submission on March 24, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2300.

Submission Details

510(k) Number	K891767 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 24, 1989
Decision Date	July 25, 1989
Days to Decision	123 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—