Medconn Glycated Hemoglobin Test system (K242911)
Description
Medconn Glycated Hemoglobin Test system by Shanghai Medconn Medical Technology Co., Ltd., an FDA 510(k) cleared clinical chemistry device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242911
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Medconn Glycated Hemoglobin Test system (K242911) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K151321 | D-100 HbA1c, D-100 HbA1c Calibrator Pack | Bio-Rad Laboratories, Inc. | 2015 |
Trace the full predicate network for K242911
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.