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FDA 510(k)

T-3 RIASSAY

K-Number: K852537 · 1985-08-12

ApplicantRia Diagnostics
Decision Date1985-08-12
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

T-3 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 1985-08-12 under 510(k) number K852537. The device is classified under product code CDP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T-3 RIASSAY?

T-3 RIASSAY is a medical device that received FDA 510(k) clearance on 1985-08-12. The listed applicant is Ria Diagnostics. The 510(k) number is K852537.

When did T-3 RIASSAY receive FDA 510(k) clearance?

T-3 RIASSAY received FDA 510(k) clearance on 1985-08-12, under 510(k) number K852537.

Who is the listed applicant for T-3 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-3 RIASSAY?

The FDA product code for T-3 RIASSAY is CDP.

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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/RIASSAYK854798T-4 RIASSAYK810296DIGOXIN RIA ASSAYK801691TSH RIASSAYK792062THEOPHYLLINE RIASSAYK780012ANTITHROMBIN III RIA

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Related Devices (Code: CDP)

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.

K001607REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)Repromedix Corp.K991692CHIRON DIAGNOSTICS ACS: 180 FT3Chiron Diagnostics Corp.K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005Biocheck, Inc.K991252AIA-PACK FT3 ASSAYTosoh Medics, Inc.K981824OPTICOAT T3 EIA KITBiotecx Laboratories, Inc.K983434ABBOTT ARCHITECT TOTAL T3Abbott Laboratories

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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