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FDA 510(k)

NETILMICIN FLUORESCENT IMMUNOASSAY

K-Number: K822941 · 1982-10-26

ApplicantAmerican Diagnostic Corp.
Decision Date1982-10-26
Product CodeLCE
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

NETILMICIN 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 1982-10-26 under 510(k) number K822941. The device is classified under product code LCE. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NETILMICIN FLUORESCENT IMMUNOASSAY?

NETILMICIN FLUORESCENT IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1982-10-26. The listed applicant is American Diagnostic Corp.. The 510(k) number is K822941.

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

NETILMICIN FLUORESCENT IMMUNOASSAY received FDA 510(k) clearance on 1982-10-26, under 510(k) number K822941.

Who is the listed applicant for NETILMICIN 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 NETILMICIN FLUORESCENT IMMUNOASSAY?

The FDA product code for NETILMICIN FLUORESCENT IMMUNOASSAY is LCE.

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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: LCE)

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.

K833715EMIT NETILMICIN ASSAYSyva Co.K832088AMES TDA NETILMICIN TEST & SERUMMiles Laboratories, Inc.K821698TDX NETILMICINAbbott LaboratoriesK821399MACRO-VUE CARD TEST, NETILMICINBd Becton Dickinson Vacutainer Systems PreanalyticK820324EMIT AND NETILMICIN ASSAYSyva Co.

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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