FIAGEN HFSH TIME-RESOLVED FLUOROIMMUNOASSAY KIT— 510(k) K884708

Name: FDA 510(k) clearance K884708
Creator: U.S. Food and Drug Administration
Published: 1989-01-17

Substantially Equivalent

Cyberfluor, Inc.

FDA 510(k) clearance K884708 for FIAGEN HFSH TIME-RESOLVED FLUOROIMMUNOASSAY KIT, Substantially Equivalent on 1989-01-17. Applicant: Cyberfluor, Inc.. Device class: 1.

Clearance details

Applicant: Cyberfluor, Inc.
Product code: Code CGJ
Device class: Class 1
Regulation: 21 CFR 862.1300
Advisory panel: Clinical Chemistry
Date received: 1988-11-09
Decision date: 1989-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario M5t 1x4, CA

Download summary PDF View on FDA.gov ↗

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