510(k) K013078— ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752

Substantially Equivalent

Helena Laboratories

Clearance details

Applicant: Helena Laboratories
Product code: Code JBP
Advisory panel: Hematology
Date received: 2001-09-14
Decision date: 2002-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

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