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FDA 510(k)

THYROXINE EMIA

K-Number: K840241 · 1984-03-30

ApplicantCollaborative Research, Inc.
Decision Date1984-03-30
Product CodeKLI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

THYROXINE EMIA is the device name listed in this FDA 510(k) record. The listed applicant is Collaborative Research, Inc.. It received FDA 510(k) clearance on 1984-03-30 under 510(k) number K840241. 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 THYROXINE EMIA?

THYROXINE EMIA is a medical device that received FDA 510(k) clearance on 1984-03-30. The listed applicant is Collaborative Research, Inc.. The 510(k) number is K840241.

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

THYROXINE EMIA received FDA 510(k) clearance on 1984-03-30, under 510(k) number K840241.

Who is the listed applicant for THYROXINE EMIA?

The FDA 510(k) record lists Collaborative Research, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THYROXINE EMIA?

The FDA product code for THYROXINE EMIA is KLI.

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Other records listing Collaborative Research, 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.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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