Helena HBF Quiplate Control

FDA 510(k) K812226 · Helena Laboratories

Substantially Equivalent

510(k) numberK812226

Submission

Device name
Helena HBF Quiplate Control
Applicant
Helena Laboratories
Mchenry, IL, US
Received
August 10, 1981
Decision date
September 1, 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

510(k)DeviceApplicantDecision
K880653HBF DiluentKQI · Traditional Helena Laboratories04/21/1988SE
K810475Helena Hemoglobin F ControlsKQI · Traditional Helena Laboratories03/26/1981SE
K791143Sickle-Cell F TestKQI · Traditional Isolab, Inc.07/17/1979SE

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Questions and answers

When was Helena HBF Quiplate Control cleared by the FDA?

Helena HBF Quiplate Control (K812226) received a 510(k) decision of Substantially Equivalent on September 1, 1981, 22 days after the submission was received.

What is the product code of K812226?

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