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FDA 510(k)

PRIMIDONE FLUORESCENT IMMUNOASSAY

K-Number: K822229 · 1982-08-12

ApplicantAmerican Diagnostic Corp.
Decision Date1982-08-12
Product CodeLFT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

PRIMIDONE 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 1982-08-12 under 510(k) number K822229. The device is classified under product code LFT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRIMIDONE FLUORESCENT IMMUNOASSAY?

PRIMIDONE FLUORESCENT IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1982-08-12. The listed applicant is American Diagnostic Corp.. The 510(k) number is K822229.

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

PRIMIDONE FLUORESCENT IMMUNOASSAY received FDA 510(k) clearance on 1982-08-12, under 510(k) number K822229.

Who is the listed applicant for PRIMIDONE 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 PRIMIDONE FLUORESCENT IMMUNOASSAY?

The FDA product code for PRIMIDONE FLUORESCENT IMMUNOASSAY is LFT.

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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: LFT)

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.

K950028PRIMIDONE FPIA REAGENT SET AND CALIBRATORSSigma Diagnostics, Inc.K904683STRATUS PRIMIDONE FLUOROMETRIC ENZYMEBaxter Healthcare CorpK895567PRIMIDONE (FPIA) KITTudor Laboratories, Inc.K852318COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORSRoche Diagnostic Systems, Inc.K842196STRATUS PRIMIDONE FLOROMETRIC ENZYAmerican DadeK823741ADVANCE EMIT-AED PRIMEDONE ASSAYSyva Co.

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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