Hemocue HBA1C 501 Glycosylated Hemoglobin Monitoring System
FDA 510(k) K141750 · Infopia Co, Ltd.
510(k) numberK141750
Submission
- Device name
- Hemocue HBA1C 501 Glycosylated Hemoglobin Monitoring System
- Applicant
- Infopia Co, Ltd.
Fullerton, CA, US - Received
- June 30, 2014
- Decision date
- July 24, 2014
- 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 Hemocue HBA1C 501 Glycosylated Hemoglobin Monitoring System cleared by the FDA?
Hemocue HBA1C 501 Glycosylated Hemoglobin Monitoring System (K141750) received a 510(k) decision of Substantially Equivalent on July 24, 2014, 24 days after the submission was received.
What is the product code of K141750?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.