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FDA 510(k)

DETECT

K-Number: K121206 · 2013-01-10

ApplicantForum Engineering Technologies, Ltd.
Decision Date2013-01-10
Product CodeLQY
DecisionSubstantially Equivalent

Device Summary

DETECT is the device name listed in this FDA 510(k) record. The listed applicant is Forum Engineering Technologies, Ltd.. It received FDA 510(k) clearance on 2013-01-10 under 510(k) number K121206. The device is classified under product code LQY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DETECT?

DETECT is a medical device that received FDA 510(k) clearance on 2013-01-10. The listed applicant is Forum Engineering Technologies, Ltd.. The 510(k) number is K121206.

When did DETECT receive FDA 510(k) clearance?

DETECT received FDA 510(k) clearance on 2013-01-10, under 510(k) number K121206.

Who is the listed applicant for DETECT?

The FDA 510(k) record lists Forum Engineering Technologies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DETECT?

The FDA product code for DETECT is LQY.

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Related PubMed Literature

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.

PMID: 40801347Loop-mediated isothermal amplification (LAMP)-based microbial detection: a review of FDA-authorized tests and future perspectives.Critical reviews in clinical laboratory sciences ()PMID: 32128936Medical device active surveillance of spontaneous reports: A literature review of signal detection methods.Pharmacoepidemiology and drug safety ()PMID: 31625336[Researching on the Classification of Computer Aided Diagnosis/Detection Software].Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation ()PMID: 29111623Medical Devices; Exemption From Premarket Notification; Class II Devices; Autosomal Recessive Carrier Screening Gene Mutation Detection System. Final order.Federal register ()

Related Devices (Code: LQY)

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.

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Official Source

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

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