HELENA HEMOGLOBIN F CONTROLS— 510(k) K810475

Name: FDA 510(k) clearance K810475
Creator: U.S. Food and Drug Administration
Published: 1981-03-26

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K810475 for HELENA HEMOGLOBIN F CONTROLS, Substantially Equivalent on 1981-03-26. Applicant: Helena Laboratories. Device class: 2.

Clearance details

Applicant: Helena Laboratories
Product code: Code KQI
Device class: Class 2
Regulation: 21 CFR 864.7455
Advisory panel: Hematology
Date received: 1981-02-23
Decision date: 1981-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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