The following data is part of a premarket notification filed by Sekisui Diagnostics P.e.i. Inc. with the FDA for Sekure Creatine Kinase Assay.
| Device ID | K182702 |
| 510k Number | K182702 |
| Device Name: | SEKURE Creatine Kinase Assay |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Applicant | SEKISUI DIAGNOSTICS P.E.I. INC. 70 Watts Avenue Charlottetown, CA C1e 2b9 |
| Contact | Jeanna Macleod |
| Correspondent | Jeanna Macleod SEKISUI DIAGNOSTICS P.E.I. INC. 70 Watts Avenue Charlottetown, CA C1e 2b9 |
| Product Code | CGS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-27 |
| Decision Date | 2019-04-17 |