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FDA 510(k)

T4 RIA KIT

K-Number: K810811 · 1981-04-07

ApplicantImmuno Assay Corp.
Decision Date1981-04-07
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

T4 RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Immuno Assay Corp.. It received FDA 510(k) clearance on 1981-04-07 under 510(k) number K810811. 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 RIA KIT?

T4 RIA KIT is a medical device that received FDA 510(k) clearance on 1981-04-07. The listed applicant is Immuno Assay Corp.. The 510(k) number is K810811.

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

T4 RIA KIT received FDA 510(k) clearance on 1981-04-07, under 510(k) number K810811.

Who is the listed applicant for T4 RIA KIT?

The FDA 510(k) record lists Immuno Assay Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for T4 RIA KIT?

The FDA product code for T4 RIA KIT is CDX.

Other records listing Immuno Assay 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.

K833842RIA COAT DIGOXINK833745RIACOAT T-4K820089TSH (RIA) KITK820074CORTISOL (RIA) KITK811954COMBO-FER IRON DIAGNOSTICK811725TBG DIAGNOSTIC KIT

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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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