AVL OMNI ANALYZER— 510(k) K954018

Substantially Equivalent

Avl Scientific Corp.

FDA 510(k) clearance K954018 for AVL OMNI ANALYZER, Substantially Equivalent on 1995-10-05. Applicant: Avl Scientific Corp.. Device class: 2.

Clearance details

Applicant: Avl Scientific Corp.
Product code: Code GKR
Device class: Class 2
Regulation: 21 CFR 864.5620
Advisory panel: Hematology
Date received: 1995-08-25
Decision date: 1995-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roswell, GA, US

Download summary PDF View on FDA.gov ↗

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