FIAGEN(TM) HLH.S— 510(k) K900621

Substantially Equivalent

Cyberfluor, Inc.

FDA 510(k) clearance K900621 for FIAGEN(TM) HLH.S, Substantially Equivalent on 1990-03-01. 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: 1990-02-08
Decision date: 1990-03-01
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.