Hemoglobin A1C Control

FDA 510(k) K021484 · Canterbury Scientific , Ltd.

Substantially Equivalent

510(k) numberK021484

Submission

Device name
Hemoglobin A1C Control
Applicant
Canterbury Scientific , Ltd.
Christchurch, NZ
Received
May 8, 2002
Decision date
June 14, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LCP – Assay, Glycosylated Hemoglobin
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7470
Specialty
Hematology

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Questions and answers

When was Hemoglobin A1C Control cleared by the FDA?

Hemoglobin A1C Control (K021484) received a 510(k) decision of Substantially Equivalent on June 14, 2002, 37 days after the submission was received.

What is the product code of K021484?

The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.