Cleared Traditional

DYNATECH MR 5000, CATALOG #011-976-0600

K894687 · Dynatech Laboratories, Inc. · Microbiology
Aug 1989
Decision
37d
Days
Class 1
Risk

About This 510(k) Submission

K894687 is an FDA 510(k) clearance for the DYNATECH MR 5000, CATALOG #011-976-0600, 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 August 31, 1989, 37 days after receiving the submission on July 25, 1989. This device falls under the Microbiology review panel. Regulated under 21 CFR 862.2300.

Submission Details

510(k) Number K894687 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 1989
Decision Date August 31, 1989
Days to Decision 37 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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