The following data is part of a premarket notification filed by Sekisui Diagnostics Pei Inc. with the FDA for Sekure Acetaminophen L3k Assay.
| Device ID | K180835 |
| 510k Number | K180835 |
| Device Name: | SEKURE Acetaminophen L3K Assay |
| Classification | Colorimetry, Acetaminophen |
| 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 | LDP |
| CFR Regulation Number | 862.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-30 |
| Decision Date | 2019-02-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628063401215 | K180835 | 000 |
| 00628063401185 | K180835 | 000 |