Dimensions HB1C Kit, Model DF105A
FDA 510(k) K102510 · Siemens Healthcare Diagnostics
510(k) numberK102510
Submission
- Device name
- Dimensions HB1C Kit, Model DF105A
- Applicant
- Siemens Healthcare Diagnostics
Newark, DE, US - Received
- August 27, 2010
- Decision date
- May 13, 2011
- 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 Dimensions HB1C Kit, Model DF105A cleared by the FDA?
Dimensions HB1C Kit, Model DF105A (K102510) received a 510(k) decision of Substantially Equivalent on May 13, 2011, 259 days after the submission was received.
What is the product code of K102510?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.