ISOPROPANOL HEMOGLOBIN STABILITY TEST— 510(k) K822123

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K822123 for ISOPROPANOL HEMOGLOBIN STABILITY TEST, Substantially Equivalent on 1982-08-05. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code GKA
Advisory panel: Hematology
Date received: 1982-07-19
Decision date: 1982-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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