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FDA 510(k)

KENAMYCIN FLUORESCENT IMMUNOASSAY FIA

K-Number: K823062 · 1982-11-10

ApplicantAmerican Diagnostic Corp.
Decision Date1982-11-10
Product CodeKJI
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

KENAMYCIN FLUORESCENT IMMUNOASSAY FIA 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 1982-11-10 under 510(k) number K823062. The device is classified under product code KJI. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KENAMYCIN FLUORESCENT IMMUNOASSAY FIA?

KENAMYCIN FLUORESCENT IMMUNOASSAY FIA is a medical device that received FDA 510(k) clearance on 1982-11-10. The listed applicant is American Diagnostic Corp.. The 510(k) number is K823062.

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

KENAMYCIN FLUORESCENT IMMUNOASSAY FIA received FDA 510(k) clearance on 1982-11-10, under 510(k) number K823062.

Who is the listed applicant for KENAMYCIN FLUORESCENT IMMUNOASSAY FIA?

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 KENAMYCIN FLUORESCENT IMMUNOASSAY FIA?

The FDA product code for KENAMYCIN FLUORESCENT IMMUNOASSAY FIA is KJI.

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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: KJI)

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.

K832769AMES TDA KANAMYCIN TEST-CONTROL SERUMMiles Laboratories, Inc.K823370ADVANCE TM EMIT(R) & TM AMIKACIN ASSAYSyva Co.K822808TDX KENAMYCINAbbott LaboratoriesK782125RIA KIT, KANAMYCINDiagnostic Products Corp.K772038KANAMYCIN RIAMonitor Science Corp.

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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