Cleared Traditional

MICROLITE TUBE LUMINOMETER #011-902-0000

K890502 · Dynatech Laboratories, Inc. · Chemistry
Feb 1989
Decision
26d
Days
Class 1
Risk

About This 510(k) Submission

K890502 is an FDA 510(k) clearance for the MICROLITE TUBE LUMINOMETER #011-902-0000, 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 February 27, 1989, 26 days after receiving the submission on February 1, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2300.

Submission Details

510(k) Number K890502 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 1989
Decision Date February 27, 1989
Days to Decision 26 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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