Cleared Traditional

MICROLITE MICROTITER PLATE LUMINOMETER ML2250/MODI

K915896 · Dynatech Laboratories, Inc. · Chemistry
May 1992
Decision
137d
Days
Class 1
Risk

About This 510(k) Submission

K915896 is an FDA 510(k) clearance for the MICROLITE MICROTITER PLATE LUMINOMETER ML2250/MODI, 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 May 4, 1992, 137 days after receiving the submission on December 19, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2300.

Submission Details

510(k) Number K915896 FDA.gov
FDA Decision Cleared SESE
Date Received December 19, 1991
Decision Date May 04, 1992
Days to Decision 137 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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