HELENA COLOCHECK— 510(k) K800433

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K800433 for HELENA COLOCHECK, Substantially Equivalent on 1980-05-02. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code KHE
Advisory panel: Hematology
Date received: 1980-02-27
Decision date: 1980-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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