FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT— 510(k) K884201

Name: FDA 510(k) clearance K884201
Creator: U.S. Food and Drug Administration
Published: 1988-12-14

Substantially Equivalent

Cyberfluor, Inc.

FDA 510(k) clearance K884201 for FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT, Substantially Equivalent on 1988-12-14. Applicant: Cyberfluor, Inc.. Device class: 2.

Clearance details

Applicant: Cyberfluor, Inc.
Product code: Product code CEE
Device class: Class 2
Regulation: 21 CFR 862.1685
Advisory panel: Clinical Chemistry
Date received: 1988-10-06
Decision date: 1988-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario M5t 1x4, CA

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.