Variant II Turbo Hemoglobin A1C Program, Hemoglobin Testing System with CDM 4.0
FDA 510(k) K063400 · Bio-Rad Laboratories, Inc.
510(k) numberK063400
Submission
- Device name
- Variant II Turbo Hemoglobin A1C Program, Hemoglobin Testing System with CDM 4.0
- Applicant
- Bio-Rad Laboratories, Inc.
Hercules, CA, US - Received
- November 9, 2006
- Decision date
- December 1, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 Turbo Hemoglobin A1C Program, Hemoglobin Testing System with CDM 4.0 cleared by the FDA?
Variant II Turbo Hemoglobin A1C Program, Hemoglobin Testing System with CDM 4.0 (K063400) received a 510(k) decision of Substantially Equivalent on December 1, 2006, 22 days after the submission was received.
What is the product code of K063400?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.