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 |