Bio-Rad D-10 Dual Program
FDA 510(k) K041444 · Bio-Rad Laboratories, Inc.
510(k) numberK041444
Submission
- Device name
- Bio-Rad D-10 Dual Program
- Applicant
- Bio-Rad Laboratories, Inc.
Hercules, CA, US - Received
- June 1, 2004
- Decision date
- June 9, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 Bio-Rad D-10 Dual Program cleared by the FDA?
Bio-Rad D-10 Dual Program (K041444) received a 510(k) decision of Substantially Equivalent on June 9, 2004, 8 days after the submission was received.
What is the product code of K041444?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.