Capillarys Hemoglobin HBA1C Capillarys 2 Flex Piercing Capillarys HBA1C Controls Capillarys HBA1C C
FDA 510(k) K122101 · Sebia
510(k) numberK122101
Submission
- Device name
- Capillarys Hemoglobin HBA1C Capillarys 2 Flex Piercing Capillarys HBA1C Controls Capillarys HBA1C C
- Applicant
- Sebia
Norcross, GA, US - Received
- July 16, 2012
- Decision date
- December 6, 2012
- 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 Capillarys Hemoglobin HBA1C Capillarys 2 Flex Piercing Capillarys HBA1C Controls Capillarys HBA1C C cleared by the FDA?
Capillarys Hemoglobin HBA1C Capillarys 2 Flex Piercing Capillarys HBA1C Controls Capillarys HBA1C C (K122101) received a 510(k) decision of Substantially Equivalent on December 6, 2012, 143 days after the submission was received.
What is the product code of K122101?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.