HELENA HEMESPEC II TOTAL HEMOGLOBIN MET.— 510(k) K803016

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K803016 for HELENA HEMESPEC II TOTAL HEMOGLOBIN MET., Substantially Equivalent on 1980-12-30. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code GKR
Advisory panel: Hematology
Date received: 1980-11-28
Decision date: 1980-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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