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FDA 510(k)

T-4 RIASSAY

K-Number: K854798 · 1986-01-15

ApplicantRia Diagnostics
Decision Date1986-01-15
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

T-4 RIASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Ria Diagnostics. It received FDA 510(k) clearance on 1986-01-15 under 510(k) number K854798. 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 T-4 RIASSAY?

T-4 RIASSAY is a medical device that received FDA 510(k) clearance on 1986-01-15. The listed applicant is Ria Diagnostics. The 510(k) number is K854798.

When did T-4 RIASSAY receive FDA 510(k) clearance?

T-4 RIASSAY received FDA 510(k) clearance on 1986-01-15, under 510(k) number K854798.

Who is the listed applicant for T-4 RIASSAY?

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

What is the FDA product code for T-4 RIASSAY?

The FDA product code for T-4 RIASSAY 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 Ria Diagnostics 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.

K855033T-3 UPTAKE/RIASSAYK852537T-3 RIASSAYK810296DIGOXIN RIA ASSAYK801691TSH RIASSAYK792062THEOPHYLLINE RIASSAYK780012ANTITHROMBIN III RIA

View all 7 devices →

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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