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FDA 510(k)

1-125 LABELED TRIIODOTHYRONINE(T3)

K-Number: K803180 · 1981-01-09

ApplicantPcl-Ria, Inc.
Decision Date1981-01-09
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

1-125 LABELED TRIIODOTHYRONINE(T3) is the device name listed in this FDA 510(k) record. The listed applicant is Pcl-Ria, Inc.. It received FDA 510(k) clearance on 1981-01-09 under 510(k) number K803180. 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 1-125 LABELED TRIIODOTHYRONINE(T3)?

1-125 LABELED TRIIODOTHYRONINE(T3) is a medical device that received FDA 510(k) clearance on 1981-01-09. The listed applicant is Pcl-Ria, Inc.. The 510(k) number is K803180.

When did 1-125 LABELED TRIIODOTHYRONINE(T3) receive FDA 510(k) clearance?

1-125 LABELED TRIIODOTHYRONINE(T3) received FDA 510(k) clearance on 1981-01-09, under 510(k) number K803180.

Who is the listed applicant for 1-125 LABELED TRIIODOTHYRONINE(T3)?

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

What is the FDA product code for 1-125 LABELED TRIIODOTHYRONINE(T3)?

The FDA product code for 1-125 LABELED TRIIODOTHYRONINE(T3) is CDP.

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Other records listing Pcl-Ria, Inc. 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.

K830526B-GCG SYSTEM BY RIAK822935THYROID STIMULATING HORMONEK823014DIGOXIN KITK822612T3 UPTAKE KITSK820886THYROXINE T4 KITK820358FOLLICLE STIMULATING HORMONE KIT

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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.K983439ABBOTT ARCHITECT FREE 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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