Cleared Traditional

MLX MICROTITER PLATE LUMINOMETER

K962265 · Dynatech Laboratories, Inc. · Chemistry
Jul 1996
Decision
43d
Days
Class 1
Risk

About This 510(k) Submission

K962265 is an FDA 510(k) clearance for the MLX MICROTITER PLATE LUMINOMETER, a Culture Media, Multiple Biochemical Test (Class I — General Controls, product code JSE), submitted by Dynatech Laboratories, Inc. (Chantilly, US). The FDA issued a Cleared decision on July 25, 1996, 43 days after receiving the submission on June 12, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.2320.

Submission Details

510(k) Number K962265 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 1996
Decision Date July 25, 1996
Days to Decision 43 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JSE — Culture Media, Multiple Biochemical Test
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2320