Cleared Traditional

MICROLITE MICROTITER PLATE LUMINOMETER ML3000

K923456 · Dynatech Laboratories, Inc. · Chemistry
Oct 1992
Decision
91d
Days
Class 1
Risk

About This 510(k) Submission

K923456 is an FDA 510(k) clearance for the MICROLITE MICROTITER PLATE LUMINOMETER ML3000, a Colorimeter, Photometer, Spectrophotometer For Clinical Use (Class I — General Controls, product code JJQ), submitted by Dynatech Laboratories, Inc. (Chantilly, US). The FDA issued a Cleared decision on October 13, 1992, 91 days after receiving the submission on July 14, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2300.

Submission Details

510(k) Number K923456 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 1992
Decision Date October 13, 1992
Days to Decision 91 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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