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FDA 510(k)

T4-RIA SINGLE REAGENT

K-Number: K832468 · 1983-09-12

ApplicantFairlake Laboratories
Decision Date1983-09-12
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

T4-RIA SINGLE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Fairlake Laboratories. It received FDA 510(k) clearance on 1983-09-12 under 510(k) number K832468. 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 SINGLE REAGENT?

T4-RIA SINGLE REAGENT is a medical device that received FDA 510(k) clearance on 1983-09-12. The listed applicant is Fairlake Laboratories. The 510(k) number is K832468.

When did T4-RIA SINGLE REAGENT receive FDA 510(k) clearance?

T4-RIA SINGLE REAGENT received FDA 510(k) clearance on 1983-09-12, under 510(k) number K832468.

Who is the listed applicant for T4-RIA SINGLE REAGENT?

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

What is the FDA product code for T4-RIA SINGLE REAGENT?

The FDA product code for T4-RIA SINGLE REAGENT is CDX.

Related Clinical Trials

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.

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Other records listing Fairlake Laboratories 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.

K832469T3-RIA SINGLE REAGENT

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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