FIAGEN(TM) HLH CATALOGUE NUMBER: 102-301— 510(k) K874624

Name: FDA 510(k) clearance K874624
Creator: U.S. Food and Drug Administration
Published: 1988-01-11

Substantially Equivalent

Cyberfluor, Inc.

FDA 510(k) clearance K874624 for FIAGEN(TM) HLH CATALOGUE NUMBER: 102-301, Substantially Equivalent on 1988-01-11. Applicant: Cyberfluor, Inc.. Device class: 1.

Clearance details

Applicant: Cyberfluor, Inc.
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1987-11-10
Decision date: 1988-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario M5t 1x4, CA

Download summary PDF View on FDA.gov ↗

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