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FDA 510(k)

PHENYTOIN FLUORESCENT IMMUNOASSAY

K-Number: K813538 · 1981-12-31

ApplicantAmerican Diagnostic Corp.
Decision Date1981-12-31
Product CodeLES
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

PHENYTOIN 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 1981-12-31 under 510(k) number K813538. The device is classified under product code LES. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHENYTOIN FLUORESCENT IMMUNOASSAY?

PHENYTOIN FLUORESCENT IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1981-12-31. The listed applicant is American Diagnostic Corp.. The 510(k) number is K813538.

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

PHENYTOIN FLUORESCENT IMMUNOASSAY received FDA 510(k) clearance on 1981-12-31, under 510(k) number K813538.

Who is the listed applicant for PHENYTOIN 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 PHENYTOIN FLUORESCENT IMMUNOASSAY?

The FDA product code for PHENYTOIN FLUORESCENT IMMUNOASSAY is LES.

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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: LES)

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.

K865102IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTSSclavo, Inc.K844990SYVA ADVANCE EMIT PHENYTOIN ASSAYSyva Co.K831154STRATUS PHENYTOIN FLUOROMETRIC ENZYMEAmerican DadeK820187SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENYSyva Co.K811025AMES TDA TM PHENYTOIN TESTMiles Laboratories, Inc.K801736AMES TDA TM PHENYTOIN 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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