Cleared Traditional

MICROLITE ML 1000 MICROTITER PLATE LUMINOMETER

K913590 · Dynatech Laboratories, Inc. · Chemistry
Oct 1991
Decision
74d
Days
Class 1
Risk

About This 510(k) Submission

K913590 is an FDA 510(k) clearance for the MICROLITE ML 1000 MICROTITER PLATE LUMINOMETER, 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 25, 1991, 74 days after receiving the submission on August 12, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2300.

Submission Details

510(k) Number K913590 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 1991
Decision Date October 25, 1991
Days to Decision 74 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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