Cleared Traditional

MRX MICROPLATE READER

K943701 · Dynatech Laboratories, Inc. · Chemistry
Oct 1994
Decision
83d
Days
Class 1
Risk

About This 510(k) Submission

K943701 is an FDA 510(k) clearance for the MRX MICROPLATE READER, 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 20, 1994, 83 days after receiving the submission on July 29, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2300.

Submission Details

510(k) Number K943701 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 1994
Decision Date October 20, 1994
Days to Decision 83 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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