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FDA 510(k)

QUINIDINE FLUORESCENT IMMUNOASSAY

K-Number: K832493 · 1983-09-12

ApplicantAmerican Diagnostic Corp.
Decision Date1983-09-12
Product CodeLBZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

QUINIDINE 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 1983-09-12 under 510(k) number K832493. The device is classified under product code LBZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUINIDINE FLUORESCENT IMMUNOASSAY?

QUINIDINE FLUORESCENT IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1983-09-12. The listed applicant is American Diagnostic Corp.. The 510(k) number is K832493.

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

QUINIDINE FLUORESCENT IMMUNOASSAY received FDA 510(k) clearance on 1983-09-12, under 510(k) number K832493.

Who is the listed applicant for QUINIDINE 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 QUINIDINE FLUORESCENT IMMUNOASSAY?

The FDA product code for QUINIDINE FLUORESCENT IMMUNOASSAY is LBZ.

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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: LBZ)

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.

K052826QMS QUINIDINE. QMS QUINIDINE CALIBRATORSSeradyn, Inc.K032332ROCHE ONLINE TDM QUINIDINERoche Diagnostics Corp.K011605EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229Syva Co., Dade Behring, Inc.K964116QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)Bayer Corp.K964212QUINIDINE ENZYME IMMUNOASSAYDiagnostic Reagents, Inc.K955568INNOFLUOR QUINIDINE ASSAY SYSTEMOxis Intl., 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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