Cleared Traditional

MR 700 MICROPLATE READER 012-700-1000

K854303 · Dynatech Laboratories, Inc. · Chemistry
Nov 1985
Decision
25d
Days
Class 1
Risk

About This 510(k) Submission

K854303 is an FDA 510(k) clearance for the MR 700 MICROPLATE READER 012-700-1000, a Colorimeter, Photometer, Spectrophotometer For Clinical Use (Class I — General Controls, product code JJQ), submitted by Dynatech Laboratories, Inc. (Alexandria, US). The FDA issued a Cleared decision on November 19, 1985, 25 days after receiving the submission on October 25, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2300.

Submission Details

510(k) Number K854303 FDA.gov
FDA Decision Cleared SESE
Date Received October 25, 1985
Decision Date November 19, 1985
Days to Decision 25 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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