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FDA 510(k)

SEKURE Acetaminophen L3K Assay

K-Number: K180835 · 2019-02-08

ApplicantSekisui Diagnostics P.E.I., Inc.
Decision Date2019-02-08
Product CodeLDP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SEKURE Acetaminophen L3K Assay is a medical device manufactured by Sekisui Diagnostics P.E.I., Inc.. It received FDA 510(k) clearance on 2019-02-08 under approval number K180835. The device is classified under product code LDP. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEKURE Acetaminophen L3K Assay?

SEKURE Acetaminophen L3K Assay is a medical device that received FDA 510(k) clearance on 2019-02-08. It is manufactured by Sekisui Diagnostics P.E.I., Inc.. The 510(k) number is K180835.

When was SEKURE Acetaminophen L3K Assay approved by the FDA?

SEKURE Acetaminophen L3K Assay received FDA 510(k) clearance on 2019-02-08, under approval number K180835.

What company makes SEKURE Acetaminophen L3K Assay?

SEKURE Acetaminophen L3K Assay is manufactured by Sekisui Diagnostics P.E.I., Inc..

What is the FDA product code for SEKURE Acetaminophen L3K Assay?

The FDA product code for SEKURE Acetaminophen L3K Assay is LDP.

Other Devices by Sekisui Diagnostics P.E.I., Inc.

K163078DC-UIBC-CAL K173206SEKURE HbA1c Assay K182702SEKURE Creatine Kinase Assay K202644Acetaminophen

Related Devices (Code: LDP)

K202644AcetaminophenSekisui Diagnostics P.E.I., Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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