Variant II Turbo Link Hemoglobin A1C Program, and Variant II Turbo Link Hemoglobin Testing with Model, 270-2716,

FDA 510(k) K070819 · Bio-Rad Laboratories Inc., Clinical Systems Divisi

Substantially Equivalent

510(k) numberK070819

Submission

Device name
Variant II Turbo Link Hemoglobin A1C Program, and Variant II Turbo Link Hemoglobin Testing with Model, 270-2716,
Applicant
Bio-Rad Laboratories Inc., Clinical Systems Divisi
Hercules, CA, US
Received
March 26, 2007
Decision date
June 25, 2007
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 Variant II Turbo Link Hemoglobin A1C Program, and Variant II Turbo Link Hemoglobin Testing with Model, 270-2716, cleared by the FDA?

Variant II Turbo Link Hemoglobin A1C Program, and Variant II Turbo Link Hemoglobin Testing with Model, 270-2716, (K070819) received a 510(k) decision of Substantially Equivalent on June 25, 2007, 91 days after the submission was received.

What is the product code of K070819?

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