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FDA 510(k)

TDX THYROXINE

K-Number: K830683 · 1983-04-06

ApplicantAbbott Laboratories
Decision Date1983-04-06
Product CodeKLI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TDX THYROXINE is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1983-04-06 under 510(k) number K830683. The device is classified under product code KLI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TDX THYROXINE?

TDX THYROXINE is a medical device that received FDA 510(k) clearance on 1983-04-06. The listed applicant is Abbott Laboratories. The 510(k) number is K830683.

When did TDX THYROXINE receive FDA 510(k) clearance?

TDX THYROXINE received FDA 510(k) clearance on 1983-04-06, under 510(k) number K830683.

Who is the listed applicant for TDX THYROXINE?

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

What is the FDA product code for TDX THYROXINE?

The FDA product code for TDX THYROXINE is KLI.

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Other records listing Abbott Laboratories as applicant

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Related Devices (Code: KLI)

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.

K160495VITROS® Automation SolutionsOrtho-Clinical Diagnostics, Inc.K131515ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENTAlfa WassermannK103484GSP NEONATAL THYROXINE (T4)Wallac Oy, A Subsidiary of Perkinelmer, Inc.K082638ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELLSiemens Healthcare Diagnostics, Inc.K030860ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300MonobindK023369ACCESS TOTAL T4 ASSAYBeckman Coulter, Inc.

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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