Variant II Hemoglobin A1C Program with Models 270-2101NU
FDA 510(k) K070452 · Bio-Rad Laboratories, Inc.
510(k) numberK070452
Submission
- Device name
- Variant II Hemoglobin A1C Program with Models 270-2101NU
- Applicant
- Bio-Rad Laboratories, Inc.
Hercules, CA, US - Received
- February 16, 2007
- Decision date
- May 7, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 Hemoglobin A1C Program with Models 270-2101NU cleared by the FDA?
Variant II Hemoglobin A1C Program with Models 270-2101NU (K070452) received a 510(k) decision of Substantially Equivalent on May 7, 2007, 80 days after the submission was received.
What is the product code of K070452?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.