AVL OPTI CRITICAL CARE ANALYZER— 510(k) K984299

Name: FDA 510(k) clearance K984299
Creator: U.S. Food and Drug Administration
Published: 1998-12-11

Substantially Equivalent

Avl Scientific Corp.

FDA 510(k) clearance K984299 for AVL OPTI CRITICAL CARE ANALYZER, Substantially Equivalent on 1998-12-11. Applicant: Avl Scientific Corp.. Device class: 2.

Clearance details

Applicant: Avl Scientific Corp.
Product code: Code JFP
Device class: Class 2
Regulation: 21 CFR 862.1145
Advisory panel: Clinical Chemistry
Date received: 1998-12-01
Decision date: 1998-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roswell, GA, US

Download summary PDF View on FDA.gov ↗

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