Cleared Traditional

DYNATECH MR4000 MICROPLATE READER

K904567 · Dynatech Corp. · Microbiology
Jan 1991
Decision
111d
Days
Class 1
Risk

About This 510(k) Submission

K904567 is an FDA 510(k) clearance for the DYNATECH MR4000 MICROPLATE READER, a Colorimeter, Photometer, Spectrophotometer For Clinical Use (Class I — General Controls, product code JJQ), submitted by Dynatech Corp. (Chantilly, US). The FDA issued a Cleared decision on January 28, 1991, 111 days after receiving the submission on October 9, 1990. This device falls under the Microbiology review panel. Regulated under 21 CFR 862.2300.

Submission Details

510(k) Number K904567 FDA.gov
FDA Decision Cleared SESE
Date Received October 09, 1990
Decision Date January 28, 1991
Days to Decision 111 days
Submission Type Traditional
Review Panel Microbiology (MI)
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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