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FDA 510(k)

T3-RIA SINGLE REAGENT

K-Number: K832469 · 1983-09-12

ApplicantFairlake Laboratories
Decision Date1983-09-12
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

T3-RIA SINGLE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Fairlake Laboratories. It received FDA 510(k) clearance on 1983-09-12 under 510(k) number K832469. 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 SINGLE REAGENT?

T3-RIA SINGLE REAGENT is a medical device that received FDA 510(k) clearance on 1983-09-12. The listed applicant is Fairlake Laboratories. The 510(k) number is K832469.

When did T3-RIA SINGLE REAGENT receive FDA 510(k) clearance?

T3-RIA SINGLE REAGENT received FDA 510(k) clearance on 1983-09-12, under 510(k) number K832469.

Who is the listed applicant for T3-RIA SINGLE REAGENT?

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

What is the FDA product code for T3-RIA SINGLE REAGENT?

The FDA product code for T3-RIA SINGLE REAGENT is CDP.

Related Clinical Trials

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.

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Other records listing Fairlake Laboratories 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.

K832468T4-RIA SINGLE REAGENT

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

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