APTT-ES— 510(k) K935169

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K935169 for APTT-ES, Substantially Equivalent on 1994-12-02. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code GFO
Advisory panel: Hematology
Date received: 1993-10-26
Decision date: 1994-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

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