THE FIAX 5000 FLUOROMETER— 510(k) K863434

Name: FDA 510(k) clearance K863434
Creator: U.S. Food and Drug Administration
Published: 1986-10-29

Substantially Equivalent

Whittaker Bioproducts, Inc.

FDA 510(k) clearance K863434 for THE FIAX 5000 FLUOROMETER, Substantially Equivalent on 1986-10-29. Applicant: Whittaker Bioproducts, Inc.. Device class: 1.

Clearance details

Applicant: Whittaker Bioproducts, Inc.
Product code: Code JZT
Device class: Class 1
Regulation: 21 CFR 866.4520
Advisory panel: Immunology
Date received: 1986-09-04
Decision date: 1986-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walkersville, MD, US

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