Helena Hemoglobin F Controls

FDA 510(k) K810475 · Helena Laboratories

Substantially Equivalent

510(k) numberK810475

Submission

Device name
Helena Hemoglobin F Controls
Applicant
Helena Laboratories
Mchenry, IL, US
Received
February 23, 1981
Decision date
March 26, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KQI – Assay, Fetal Hemoglobin
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7455
Specialty
Hematology

Other 510(k)s with product code KQI

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K880653HBF DiluentKQI · Traditional Helena Laboratories04/21/1988SE
K812226Helena HBF Quiplate ControlKQI · Traditional Helena Laboratories09/01/1981SE
K791143Sickle-Cell F TestKQI · Traditional Isolab, Inc.07/17/1979SE

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Questions and answers

When was Helena Hemoglobin F Controls cleared by the FDA?

Helena Hemoglobin F Controls (K810475) received a 510(k) decision of Substantially Equivalent on March 26, 1981, 31 days after the submission was received.

What is the product code of K810475?

The FDA product code is KQI – Assay, Fetal Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7455.