The following data is part of a premarket notification filed by Sekisui Diagnostics Pei Inc. with the FDA for Sekure Hba1c Assay.
| Device ID | K173206 |
| 510k Number | K173206 |
| Device Name: | SEKURE HbA1c Assay |
| Classification | Hemoglobin A1c Test System |
| Applicant | Sekisui Diagnostics PEI Inc. 70 Watts Avenue Charlottetown, CA C1e 2b9 |
| Contact | Penny White |
| Correspondent | Penny White Sekisui Diagnostics PEI Inc. 70 Watts Avenue Charlottetown, CA C1e 2b9 |
| Product Code | PDJ |
| CFR Regulation Number | 862.1373 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-02 |
| Decision Date | 2018-07-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628063401147 | K173206 | 000 |