Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

T3 (RIA) KIT

K-Number: K811213 · 1981-05-29

ApplicantImmuno Assay Corp.
Decision Date1981-05-29
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

T3 (RIA) KIT is the device name listed in this FDA 510(k) record. The listed applicant is Immuno Assay Corp.. It received FDA 510(k) clearance on 1981-05-29 under 510(k) number K811213. 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 T3 (RIA) KIT?

T3 (RIA) KIT is a medical device that received FDA 510(k) clearance on 1981-05-29. The listed applicant is Immuno Assay Corp.. The 510(k) number is K811213.

When did T3 (RIA) KIT receive FDA 510(k) clearance?

T3 (RIA) KIT received FDA 510(k) clearance on 1981-05-29, under 510(k) number K811213.

Who is the listed applicant for T3 (RIA) KIT?

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

What is the FDA product code for T3 (RIA) KIT?

The FDA product code for T3 (RIA) KIT is CDP.

Other records listing Immuno Assay Corp. 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.

K833842RIA COAT DIGOXINK833745RIACOAT T-4K820089TSH (RIA) KITK820074CORTISOL (RIA) KITK811954COMBO-FER IRON DIAGNOSTICK811725TBG DIAGNOSTIC KIT

View all 10 devices →

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.

↑