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FDA 510(k)

PHENOBARBITAL FLUORESCENT IMMUNO

K-Number: K821408 · 1982-05-24

ApplicantAmerican Diagnostic Corp.
Decision Date1982-05-24
Product CodeLET
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

PHENOBARBITAL FLUORESCENT IMMUNO 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 1982-05-24 under 510(k) number K821408. The device is classified under product code LET. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHENOBARBITAL FLUORESCENT IMMUNO?

PHENOBARBITAL FLUORESCENT IMMUNO is a medical device that received FDA 510(k) clearance on 1982-05-24. The listed applicant is American Diagnostic Corp.. The 510(k) number is K821408.

When did PHENOBARBITAL FLUORESCENT IMMUNO receive FDA 510(k) clearance?

PHENOBARBITAL FLUORESCENT IMMUNO received FDA 510(k) clearance on 1982-05-24, under 510(k) number K821408.

Who is the listed applicant for PHENOBARBITAL FLUORESCENT IMMUNO?

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 PHENOBARBITAL FLUORESCENT IMMUNO?

The FDA product code for PHENOBARBITAL FLUORESCENT IMMUNO is LET.

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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: LET)

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.

K901537MODIFIED OPUS PHENOBARBITAL TEST SYSTEMPb Diagnostic Systems, Inc.K865000IMMPULSE COATED TUBE PHENOBARBITAL ASSAY REAGENTSSclavo, Inc.K842592AMES TDA PHENOBARBITAL TESTMiles Laboratories, Inc.K830701STRATUS PHENOBARBITAL FLUOROMETRIC ENZAmerican DadeK820188PHENOBARBITAL ASSAYSyva Co.K810994AMES TDA TM PHENOBARBITAL TESTMiles 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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