SPECIALTY ASSAYED CONTROL-2— 510(k) K100103

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K100103 for SPECIALTY ASSAYED CONTROL-2, Substantially Equivalent on 2010-12-15. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code GGC
Advisory panel: Hematology
Date received: 2010-01-13
Decision date: 2010-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

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