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FDA 510(k)

T3(125) RADIOIMMUNOASSAY KIT

K-Number: K801843 · 1980-09-16

ApplicantTechnia Diagnostics , Ltd.
Decision Date1980-09-16
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

T3(125) RADIOIMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Technia Diagnostics , Ltd.. It received FDA 510(k) clearance on 1980-09-16 under 510(k) number K801843. 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(125) RADIOIMMUNOASSAY KIT?

T3(125) RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1980-09-16. The listed applicant is Technia Diagnostics , Ltd.. The 510(k) number is K801843.

When did T3(125) RADIOIMMUNOASSAY KIT receive FDA 510(k) clearance?

T3(125) RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1980-09-16, under 510(k) number K801843.

Who is the listed applicant for T3(125) RADIOIMMUNOASSAY KIT?

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

What is the FDA product code for T3(125) RADIOIMMUNOASSAY KIT?

The FDA product code for T3(125) RADIOIMMUNOASSAY KIT is CDP.

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Other records listing Technia Diagnostics , Ltd. 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.

K861978AUTOFLUOR VK801202DIGOXIN RADIOIMMUNOASSAY KITK801203CORTISOL RADIOIMMUNOASSAY KITK791361T3 UPTAKE RADIOIMMUNOASSAY KITK790919HPL RIA KITK790495THYROXINE RIA 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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