ACE COLOR TEST— 510(k) K833933

Substantially Equivalent

Hana Biologics, Inc.

FDA 510(k) clearance K833933 for ACE COLOR TEST, Substantially Equivalent on 1984-03-23. Applicant: Hana Biologics, Inc.. Device class: 2.

Clearance details

Applicant: Hana Biologics, Inc.
Product code: Code KQN
Device class: Class 2
Regulation: 21 CFR 862.1090
Advisory panel: Clinical Chemistry
Date received: 1983-11-14
Decision date: 1984-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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