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FDA 510(k)

AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM

K-Number: K820397 · 1982-03-02

ApplicantAmerican Diagnostic Corp.
Decision Date1982-03-02
Product CodeLER
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM 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 1982-03-02 under 510(k) number K820397. The device is classified under product code LER. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM?

AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM is a medical device that received FDA 510(k) clearance on 1982-03-02. The listed applicant is American Diagnostic Corp.. The 510(k) number is K820397.

When did AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM receive FDA 510(k) clearance?

AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM received FDA 510(k) clearance on 1982-03-02, under 510(k) number K820397.

Who is the listed applicant for AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM?

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 AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM?

The FDA product code for AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM is LER.

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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: LER)

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.

K942192THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORSSigma Diagnostics, Inc.K905521CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATIONMicrogenics Corp.K882570TURBOX THEOPHYLLINE ASSAYUnipath , Ltd.K864409IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTSSclavo, Inc.K863475THEOFAST(TM) TEST PACKAGE3M CompanyK842585THEOPHYLLINE KIT FLUORESCENCE POLARIZA-Windsor Laboratories, 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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