QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE)— 510(k) K973335

Name: FDA 510(k) clearance K973335
Creator: U.S. Food and Drug Administration
Published: 1998-04-30

Substantially Equivalent

Zenyx Scientific , Ltd.

FDA 510(k) clearance K973335 for QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE), Substantially Equivalent on 1998-04-30. Applicant: Zenyx Scientific , Ltd.. Device class: 1.

Clearance details

Applicant: Zenyx Scientific , Ltd.
Product code: Code JQW
Device class: Class 1
Regulation: 21 CFR 862.2750
Advisory panel: Clinical Chemistry
Date received: 1997-09-04
Decision date: 1998-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cheadle, Cheshire, GB

Download summary PDF View on FDA.gov ↗

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