K252749 is an FDA 510(k) clearance for the Medconn 8K Glycated Hemoglobin Test System. This device is classified as a Hemoglobin A1c Test System (Class II - Special Controls, product code PDJ).
Submitted by Shanghai Medconn Medical Technology Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on January 6, 2026, 130 days after receiving the submission on August 29, 2025.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1373. Quantitative Determination Of Hemoglobin A1c To Aid In The Diagnosis Of Diabetes..
| 510(k) Number | K252749 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 2025 |
| Decision Date | January 06, 2026 |
| Days to Decision | 130 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | PDJ - Hemoglobin A1c Test System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1373 |
| Definition | Quantitative Determination Of Hemoglobin A1c To Aid In The Diagnosis Of Diabetes. |