Cleared Traditional

MICROPLATE LUMINOMETER ML 1000 (NO. 012-101-000)

K871415 · Dynatech Laboratories, Inc. · Chemistry
Apr 1987
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K871415 is an FDA 510(k) clearance for the MICROPLATE LUMINOMETER ML 1000 (NO. 012-101-000), 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 April 22, 1987, 14 days after receiving the submission on April 8, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2300.

Submission Details

510(k) Number K871415 FDA.gov
FDA Decision Cleared SESE
Date Received April 08, 1987
Decision Date April 22, 1987
Days to Decision 14 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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