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FDA 510(k)

AMIKACIN FLUORESCENT IMMUNOASSAY

K-Number: K813541 · 1982-01-12

ApplicantAmerican Diagnostic Corp.
Decision Date1982-01-12
Product CodeKLQ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AMIKACIN 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 1982-01-12 under 510(k) number K813541. The device is classified under product code KLQ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMIKACIN FLUORESCENT IMMUNOASSAY?

AMIKACIN FLUORESCENT IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1982-01-12. The listed applicant is American Diagnostic Corp.. The 510(k) number is K813541.

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

AMIKACIN FLUORESCENT IMMUNOASSAY received FDA 510(k) clearance on 1982-01-12, under 510(k) number K813541.

Who is the listed applicant for AMIKACIN 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 AMIKACIN FLUORESCENT IMMUNOASSAY?

The FDA product code for AMIKACIN FLUORESCENT IMMUNOASSAY is KLQ.

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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: KLQ)

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.

K052815QMS AMIKACIN REAGENTSSeradyn, Inc.K033884RANDOX AMIKACINRandox Laboratories, Ltd.K955570INNOFLUOR AMIKACIN ASSAY SYSTEMOxis Intl., Inc.K903100INNOFLUOR (TM) AMIKACIN REAGENT SETInnotron of Oregon, Inc.K894517FPR AMIKACIN KITColony Laboratories, Inc.K852317COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATORRoche 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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