Cleared Traditional

K863434 - THE FIAX 5000 FLUOROMETER
(FDA 510(k) Clearance)

K863434 · Whittaker Bioproducts, Inc. · Immunology

Oct 1986

Decision

55d

Days

Class 1

Risk

K863434 is an FDA 510(k) clearance for the THE FIAX 5000 FLUOROMETER. This device is classified as a Fluorometer (Class I — General Controls, product code JZT).

Submitted by Whittaker Bioproducts, Inc. (Walkersville, US). The FDA issued a Cleared decision on October 29, 1986, 55 days after receiving the submission on September 4, 1986.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.4520.

Submission Details

510(k) Number	K863434 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 04, 1986
Decision Date	October 29, 1986
Days to Decision	55 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	—