Cleared Traditional

ICON READER

K862956 · Hybritech, Inc. · Chemistry
Aug 1986
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K862956 is an FDA 510(k) clearance for the ICON READER, a Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica (Class I — General Controls, product code JQT), submitted by Hybritech, Inc. (San Diego, US). The FDA issued a Cleared decision on August 19, 1986, 14 days after receiving the submission on August 5, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2400.

Submission Details

510(k) Number K862956 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 1986
Decision Date August 19, 1986
Days to Decision 14 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JQT — Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2400