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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 the device name listed in this FDA 510(k) record. The listed applicant is Sekisui Diagnostics P.E.I., Inc.. It received FDA 510(k) clearance on 2019-02-08 under 510(k) 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. The listed applicant is Sekisui Diagnostics P.E.I., Inc.. The 510(k) number is K180835.

When did SEKURE Acetaminophen L3K Assay receive FDA 510(k) clearance?

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

Who is the listed applicant for SEKURE Acetaminophen L3K Assay?

The FDA 510(k) record lists Sekisui Diagnostics P.E.I., Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Sekisui Diagnostics P.E.I., Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K202644AcetaminophenK182702SEKURE Creatine Kinase AssayK173206SEKURE HbA1c AssayK163078DC-UIBC-CAL

Related Devices (Code: LDP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261364Atellica CH Acetaminophen 2 (ACTM)Siemens Healthcare Diagnostics, Inc.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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