TITAN GEL-PC GLYCO-HEME(TM) SYSTEM— 510(k) K880698

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K880698 for TITAN GEL-PC GLYCO-HEME(TM) SYSTEM, Substantially Equivalent on 1988-05-06. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code LCP
Advisory panel: Hematology
Date received: 1988-02-22
Decision date: 1988-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

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