D-10 Hemoglobin A1C Program; D-10 Dual Program
FDA 510(k) K060001 · Bio-Rad Laboratories, Inc.
510(k) numberK060001
Submission
- Device name
- D-10 Hemoglobin A1C Program; D-10 Dual Program
- Applicant
- Bio-Rad Laboratories, Inc.
Hercules, CA, US - Received
- January 3, 2006
- Decision date
- January 20, 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 D-10 Hemoglobin A1C Program; D-10 Dual Program cleared by the FDA?
D-10 Hemoglobin A1C Program; D-10 Dual Program (K060001) received a 510(k) decision of Substantially Equivalent on January 20, 2006, 17 days after the submission was received.
What is the product code of K060001?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.