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 |