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FDA 510(k)

LIDOCAINE FLUORESCENT IMMUNOASSAY

K-Number: K822347 · 1982-08-25

ApplicantAmerican Diagnostic Corp.
Decision Date1982-08-25
Product CodeKLR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

LIDOCAINE FLUORESCENT IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is American Diagnostic Corp.. It received FDA 510(k) clearance on 1982-08-25 under 510(k) number K822347. 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 LIDOCAINE FLUORESCENT IMMUNOASSAY?

LIDOCAINE FLUORESCENT IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1982-08-25. The listed applicant is American Diagnostic Corp.. The 510(k) number is K822347.

When did LIDOCAINE FLUORESCENT IMMUNOASSAY receive FDA 510(k) clearance?

LIDOCAINE FLUORESCENT IMMUNOASSAY received FDA 510(k) clearance on 1982-08-25, under 510(k) number K822347.

Who is the listed applicant for LIDOCAINE FLUORESCENT IMMUNOASSAY?

The FDA 510(k) record lists American Diagnostic Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIDOCAINE FLUORESCENT IMMUNOASSAY?

The FDA product code for LIDOCAINE FLUORESCENT IMMUNOASSAY is KLR.

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Other records listing American Diagnostic Corp. 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.

K162589Adscope 658 Electronic StethoscopeK093495OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITSK060321ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BKK012304ADC 656 ELECTRONIC STETHOSCOPEK962655ANEROID AND MERCURIAL SPHYGMOMANOMETERSK940686ELECTRONIC THERMOMETERS

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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.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.

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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