Cleared Traditional

MR 600 MICROPLATE READER

K821439 · Dynatech Corp. · Chemistry
Jun 1982
Decision
19d
Days
Class 1
Risk

About This 510(k) Submission

K821439 is an FDA 510(k) clearance for the MR 600 MICROPLATE READER, a Colorimeter, Photometer, Spectrophotometer For Clinical Use (Class I — General Controls, product code JJQ), submitted by Dynatech Corp. (Mchenry, US). The FDA issued a Cleared decision on June 1, 1982, 19 days after receiving the submission on May 13, 1982. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2300.

Submission Details

510(k) Number K821439 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 1982
Decision Date June 01, 1982
Days to Decision 19 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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