Cleared Traditional

ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER

K962499 · Bartels, Inc. · Immunology

Sep 1996

Decision

71d

Days

Class 1

Risk

About This 510(k) Submission

K962499 is an FDA 510(k) clearance for the ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER, a Fluorometer (Class I — General Controls, product code JZT), submitted by Bartels, Inc. (Issaquah, US). The FDA issued a Cleared decision on September 5, 1996, 71 days after receiving the submission on June 26, 1996. This device falls under the Immunology review panel. Regulated under 21 CFR 866.4520.

Submission Details

510(k) Number	K962499 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 26, 1996
Decision Date	September 05, 1996
Days to Decision	71 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF