TITANGEL HIGH RESOLUTION CONTROL— 510(k) K833639

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K833639 for TITANGEL HIGH RESOLUTION CONTROL, Substantially Equivalent on 1984-01-04. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code JJY
Advisory panel: Clinical Chemistry
Date received: 1983-10-17
Decision date: 1984-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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