Cleared Traditional

LABOTECH AUTOMATED MICROTITER ANALYZER

K922081 · Innovative Medical Systems, Inc. · Chemistry
Sep 1992
Decision
120d
Days
Class 1
Risk

About This 510(k) Submission

K922081 is an FDA 510(k) clearance for the LABOTECH AUTOMATED MICROTITER ANALYZER, a Colorimeter, Photometer, Spectrophotometer For Clinical Use (Class I — General Controls, product code JJQ), submitted by Innovative Medical Systems, Inc. (Warren, US). The FDA issued a Cleared decision on September 2, 1992, 120 days after receiving the submission on May 5, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2300.

Submission Details

510(k) Number K922081 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 1992
Decision Date September 02, 1992
Days to Decision 120 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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