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FDA 510(k)

THYROXINE (T4) 125I

K-Number: K812666 · 1981-10-02

ApplicantPcl-Ria, Inc.
Decision Date1981-10-02
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

THYROXINE (T4) 125I 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 1981-10-02 under 510(k) number K812666. 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 THYROXINE (T4) 125I?

THYROXINE (T4) 125I is a medical device that received FDA 510(k) clearance on 1981-10-02. The listed applicant is Pcl-Ria, Inc.. The 510(k) number is K812666.

When did THYROXINE (T4) 125I receive FDA 510(k) clearance?

THYROXINE (T4) 125I received FDA 510(k) clearance on 1981-10-02, under 510(k) number K812666.

Who is the listed applicant for THYROXINE (T4) 125I?

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 THYROXINE (T4) 125I?

The FDA product code for THYROXINE (T4) 125I 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.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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