Cleared Traditional

ECLIPSE ICA ANALYZER

K910302 · Biotope, Inc. · Chemistry
Feb 1991
Decision
29d
Days
Class 1
Risk

About This 510(k) Submission

K910302 is an FDA 510(k) clearance for the ECLIPSE ICA ANALYZER, a Colorimeter, Photometer, Spectrophotometer For Clinical Use (Class I — General Controls, product code JJQ), submitted by Biotope, Inc. (Redmond, US). The FDA issued a Cleared decision on February 22, 1991, 29 days after receiving the submission on January 24, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2300.

Submission Details

510(k) Number K910302 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 1991
Decision Date February 22, 1991
Days to Decision 29 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JJQ — Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2300

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