Cleared Traditional

DYNATECH MR 300 MANUAL MICROELISA

K874244 · Dynatech Laboratories, Inc. · Chemistry
Nov 1987
Decision
18d
Days
Class 1
Risk

About This 510(k) Submission

K874244 is an FDA 510(k) clearance for the DYNATECH MR 300 MANUAL MICROELISA, 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 November 3, 1987, 18 days after receiving the submission on October 16, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2300.

Submission Details

510(k) Number K874244 FDA.gov
FDA Decision Cleared SESE
Date Received October 16, 1987
Decision Date November 03, 1987
Days to Decision 18 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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