The following data is part of a premarket notification filed by Sekisui Diagnostics P.e.i. Inc. with the FDA for Acetaminophen.
| Device ID | K202644 |
| 510k Number | K202644 |
| Device Name: | Acetaminophen |
| Classification | Colorimetry, Acetaminophen |
| Applicant | Sekisui Diagnostics P.E.I. INC. 70 Watts Avenue Charlottetown, CA C1e 2b9 |
| Contact | Penny White |
| Correspondent | Penny White Sekisui Diagnostics P.E.I. 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 | 2020-09-11 |
| Decision Date | 2022-02-18 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ACETAMINOPHEN 85615223 not registered Dead/Abandoned |
General Merchandise importers and Expoters 2012-05-03 |