Sekisui Diagnostics P.E.I., Inc.
Sekisui Diagnostics P.E.I., Inc. holds FDA 510(k) medical device clearances, first cleared 2011, most recent 2022, with 2 FDA device recalls on record.
Top product codes for Sekisui Diagnostics P.E.I., Inc.
FDA recalls by Sekisui Diagnostics P.E.I., Inc.
- Z-1078-2017 — Sekisui Diagnostics Ammonia L3K¿ Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma
- Z-1171-2016 — 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 quantitative measurement of Acetaminophen in serum and plasma used m the diagnosis and treatment of acetaminophen overdose toxicity.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Sekisui Diagnostics P.E.I., Inc.
Data sourced from openFDA. This site is unofficial and independent of the FDA.