FLUORESCENCE CONCENTRATION ANALYZER (FCA)— 510(k) K864699

Name: FDA 510(k) clearance K864699
Creator: U.S. Food and Drug Administration
Published: 1986-12-22

Substantially Equivalent

Pandex Laboratories, Inc.

FDA 510(k) clearance K864699 for FLUORESCENCE CONCENTRATION ANALYZER (FCA), Substantially Equivalent on 1986-12-22. Applicant: Pandex Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Pandex Laboratories, Inc.
Product code: Code JZT
Device class: Class 1
Regulation: 21 CFR 866.4520
Advisory panel: Immunology
Date received: 1986-12-02
Decision date: 1986-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mundelein, IL, US

Download summary PDF View on FDA.gov ↗

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