Company ยท CA
Sekisui Diagnostics P.E.I., Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2022. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 18, 2022 | K202644 | Acetaminophen Sekisui Diagnostics P.E.I., Inc., CA | LDP |
| Apr 17, 2019 | K182702 | SEKURE Creatine Kinase Assay Sekisui Diagnostics P.E.I., Inc., CA | CGS |
| Feb 8, 2019 | K180835 | SEKURE Acetaminophen L3K Assay Sekisui Diagnostics P.E.I., Inc., CA | LDP |
| Jul 12, 2018 | K173206 | SEKURE HbA1c Assay Sekisui Diagnostics P.E.I., Inc., CA | PDJ |
| Dec 8, 2016 | K163078 | DC-UIBC-CAL Sekisui Diagnostics P.E.I., Inc., CA | JIT |
| Dec 2, 2011 | K111915 | MAGNESIUM ASSAY Sekisui Diagnostics P.E.I., Inc., CA | JGJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 23, 2017 | Sekisui Diagnostics P.E.I. Inc. Sekisui Diagnostics Ammonia L3K Assay; Catalog Number: 293-80-91 and 293-10
For the IN VITRO quantitative measurement of ammonia concentration in plasma Terminated |
JIF | K033921 |
| Jan 22, 2016 | Sekisui Diagnostics P.E.I. Inc. Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic
Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml
Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml
In-Vitro quant Terminated |
LDP | K081938 |