REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178— 510(k) K892424

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K892424 for REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178, Substantially Equivalent on 1989-06-09. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code CFF
Advisory panel: Immunology
Date received: 1989-04-10
Decision date: 1989-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

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