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FDA 510(k)

QMS LIDOCAINE

K-Number: K090282 · 2009-05-29

ApplicantThermo Fisher Scientific, Inc.
Decision Date2009-05-29
Product CodeKLR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

QMS LIDOCAINE is the device name listed in this FDA 510(k) record. The listed applicant is Thermo Fisher Scientific, Inc.. It received FDA 510(k) clearance on 2009-05-29 under 510(k) number K090282. The device is classified under product code KLR. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QMS LIDOCAINE?

QMS LIDOCAINE is a medical device that received FDA 510(k) clearance on 2009-05-29. The listed applicant is Thermo Fisher Scientific, Inc.. The 510(k) number is K090282.

When did QMS LIDOCAINE receive FDA 510(k) clearance?

QMS LIDOCAINE received FDA 510(k) clearance on 2009-05-29, under 510(k) number K090282.

Who is the listed applicant for QMS LIDOCAINE?

The FDA 510(k) record lists Thermo Fisher Scientific, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QMS LIDOCAINE?

The FDA product code for QMS LIDOCAINE is KLR.

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Related Devices (Code: KLR)

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.

K033809DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49DDade Behring, Inc.K032334ROCHE ONLINE TDM LIDOCAINERoche Diagnostics Corp.K973102LIDOCAINE EIA ASSAYDiagnostic Reagents, Inc.K881116EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641Diagnostic SystemsK853010COBAS REAGENT FOR LIDOCAINE & CALIBRATORSRoche Diagnostic Systems, Inc.K843184STRATUS LIDOCAINE FLUOROMETRIC ENZYMEAmerican Dade

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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