POLLER CALIBRANTS— 510(k) K991439

Name: FDA 510(k) clearance K991439
Creator: U.S. Food and Drug Administration
Published: 1999-12-20

Substantially Equivalent

European Concerted Action on Anticoagulation

FDA 510(k) clearance K991439 for POLLER CALIBRANTS, Substantially Equivalent on 1999-12-20. Applicant: European Concerted Action on Anticoagulation. Device class: 2.

Clearance details

Applicant: European Concerted Action on Anticoagulation
Product code: Code GGN
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 1999-04-26
Decision date: 1999-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Manchester, GB

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