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 |