FACTOR VIII RELATED ANTIGEN ROCKET EID— 510(k) K823267

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K823267 for FACTOR VIII RELATED ANTIGEN ROCKET EID, Substantially Equivalent on 1982-12-28. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code GGP
Advisory panel: Hematology
Date received: 1982-11-02
Decision date: 1982-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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