Cleared Traditional

MR 650 MICROPLATE READER(CAT. NO. 011-973-0500)

K852411 · Dynatech Laboratories, Inc. · Chemistry
Sep 1985
Decision
116d
Days
Class 1
Risk

About This 510(k) Submission

K852411 is an FDA 510(k) clearance for the MR 650 MICROPLATE READER(CAT. NO. 011-973-0500), 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 September 30, 1985, 116 days after receiving the submission on June 6, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2300.

Submission Details

510(k) Number K852411 FDA.gov
FDA Decision Cleared SESE
Date Received June 06, 1985
Decision Date September 30, 1985
Days to Decision 116 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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