REP(R) IMMUNOFIX— 510(k) K901805

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K901805 for REP(R) IMMUNOFIX, Substantially Equivalent on 1990-06-06. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code DAH
Advisory panel: Immunology
Date received: 1990-04-20
Decision date: 1990-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

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