Cleared Traditional

ORIGEN ANALYZER

K962166 · Igen, Inc. · Chemistry

Jul 1996

Decision

57d

Days

Class 1

Risk

About This 510(k) Submission

K962166 is an FDA 510(k) clearance for the ORIGEN ANALYZER, a Colorimeter, Photometer, Spectrophotometer For Clinical Use (Class I — General Controls, product code JJQ), submitted by Igen, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on July 31, 1996, 57 days after receiving the submission on June 4, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2300.

Submission Details

510(k) Number	K962166 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 04, 1996
Decision Date	July 31, 1996
Days to Decision	57 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF