Cleared Traditional

K864699 - FLUORESCENCE CONCENTRATION ANALYZER (FCA)
(FDA 510(k) Clearance)

K864699 · Pandex Laboratories, Inc. · Immunology

Dec 1986

Decision

20d

Days

Class 1

Risk

K864699 is an FDA 510(k) clearance for the FLUORESCENCE CONCENTRATION ANALYZER (FCA), a Fluorometer (Class I — General Controls, product code JZT), submitted by Pandex Laboratories, Inc. (Mundelein, US). The FDA issued a Cleared decision on December 22, 1986, 20 days after receiving the submission on December 2, 1986. This device falls under the Immunology review panel. Regulated under 21 CFR 866.4520.

Submission Details

510(k) Number	K864699 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 02, 1986
Decision Date	December 22, 1986
Days to Decision	20 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	—