Cleared Traditional

MICROLITE CAMERA LUMINOMETER CL 1050 (0119010000)

K884782 · Dynatech Laboratories, Inc. · Chemistry
Feb 1989
Decision
94d
Days
Class 1
Risk

About This 510(k) Submission

K884782 is an FDA 510(k) clearance for the MICROLITE CAMERA LUMINOMETER CL 1050 (0119010000), 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 17, 1989, 94 days after receiving the submission on November 15, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2300.

Submission Details

510(k) Number K884782 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 1988
Decision Date February 17, 1989
Days to Decision 94 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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