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FDA 510(k)

T4 RADIOIMMUNOASSAY KIT

K-Number: K802469 · 1980-11-12

ApplicantAmerican Diagnostic Corp.
Decision Date1980-11-12
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

T4 RADIOIMMUNOASSAY KIT 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 1980-11-12 under 510(k) number K802469. The device is classified under product code CDX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T4 RADIOIMMUNOASSAY KIT?

T4 RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1980-11-12. The listed applicant is American Diagnostic Corp.. The 510(k) number is K802469.

When did T4 RADIOIMMUNOASSAY KIT receive FDA 510(k) clearance?

T4 RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1980-11-12, under 510(k) number K802469.

Who is the listed applicant for T4 RADIOIMMUNOASSAY KIT?

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 T4 RADIOIMMUNOASSAY KIT?

The FDA product code for T4 RADIOIMMUNOASSAY KIT is CDX.

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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: CDX)

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.

K961490ELECSYS T4 ASSAYBoehringer Mannheim Corp.K954312ACTIVE THYROXINE RIADiagnostic Systems Laboratories, Inc.K943416DELFIA NEONATAL THYROXINE KITWallac OYK934384AXSYM(TM) TOTAL T4Abbott LaboratoriesK932980TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116Sigma Diagnostics, Inc.K933426STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNOBaxter Diagnostics, 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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