Cleared Traditional

MICROLITE ML 1000 (MODEL 3) MICROPLATE LUMINOMETER

K895313 · Dynatech Laboratories, Inc. · Chemistry
Oct 1989
Decision
49d
Days
Class 1
Risk

About This 510(k) Submission

K895313 is an FDA 510(k) clearance for the MICROLITE ML 1000 (MODEL 3) MICROPLATE 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 17, 1989, 49 days after receiving the submission on August 29, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2300.

Submission Details

510(k) Number K895313 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 1989
Decision Date October 17, 1989
Days to Decision 49 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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