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FDA 510(k)

GENTAMICIN FLUORESCENT IMMUNOASSAY

K-Number: K813539 · 1981-12-31

ApplicantAmerican Diagnostic Corp.
Decision Date1981-12-31
Product CodeLCQ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

GENTAMICIN 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 1981-12-31 under 510(k) number K813539. The device is classified under product code LCQ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENTAMICIN FLUORESCENT IMMUNOASSAY?

GENTAMICIN FLUORESCENT IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1981-12-31. The listed applicant is American Diagnostic Corp.. The 510(k) number is K813539.

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

GENTAMICIN FLUORESCENT IMMUNOASSAY received FDA 510(k) clearance on 1981-12-31, under 510(k) number K813539.

Who is the listed applicant for GENTAMICIN 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 GENTAMICIN FLUORESCENT IMMUNOASSAY?

The FDA product code for GENTAMICIN FLUORESCENT IMMUNOASSAY is LCQ.

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Other records listing American Diagnostic Corp. as applicant

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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: LCQ)

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.

K972609VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAMBio-RadK955569INNOFLUOR GENTAMICIN ASSAY SYSTEMOxis Intl., Inc.K945523COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORSRoche Diagnostic Systems, Inc.K943550GENTAMICIN FPIA REAGENT SET AND CALIBRATORSSigma Diagnostics, Inc.K905721OPUS GENTAMICINPb Diagnostic Systems, Inc.K904226'TDXFLX ANALYZERAbbott Laboratories

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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