TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER— 510(k) K891683

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K891683 for TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER, Substantially Equivalent on 1989-04-12. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code CZN
Advisory panel: Immunology
Date received: 1989-03-22
Decision date: 1989-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

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