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FDA 510(k)

DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D

K-Number: K033809 · 2004-02-20

ApplicantDade Behring, Inc.
Decision Date2004-02-20
Product CodeKLR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 2004-02-20 under 510(k) number K033809. 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 DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D?

DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D is a medical device that received FDA 510(k) clearance on 2004-02-20. The listed applicant is Dade Behring, Inc.. The 510(k) number is K033809.

When did DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D receive FDA 510(k) clearance?

DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D received FDA 510(k) clearance on 2004-02-20, under 510(k) number K033809.

Who is the listed applicant for DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D?

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

What is the FDA product code for DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D?

The FDA product code for DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D 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.

K090282QMS LIDOCAINEThermo Fisher Scientific, 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

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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