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FDA 510(k)

TERUMO SENSIBEAD THYROXINE EIA KIT

K-Number: K841601 · 1984-05-22

ApplicantTerumo Medical Corp.
Decision Date1984-05-22
Product CodeKLI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TERUMO SENSIBEAD THYROXINE EIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Corp.. It received FDA 510(k) clearance on 1984-05-22 under 510(k) number K841601. 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 TERUMO SENSIBEAD THYROXINE EIA KIT?

TERUMO SENSIBEAD THYROXINE EIA KIT is a medical device that received FDA 510(k) clearance on 1984-05-22. The listed applicant is Terumo Medical Corp.. The 510(k) number is K841601.

When did TERUMO SENSIBEAD THYROXINE EIA KIT receive FDA 510(k) clearance?

TERUMO SENSIBEAD THYROXINE EIA KIT received FDA 510(k) clearance on 1984-05-22, under 510(k) number K841601.

Who is the listed applicant for TERUMO SENSIBEAD THYROXINE EIA KIT?

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

What is the FDA product code for TERUMO SENSIBEAD THYROXINE EIA KIT?

The FDA product code for TERUMO SENSIBEAD THYROXINE EIA KIT is KLI.

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Other records listing Terumo Medical 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.

K111606PINNACLE PRECISION ACCESS SYSTEMK111556GLIDECROSS SUPPORT CATHETERK110540TERUMO SUPPORT CATHETERK102008GLIDESHEATHK091329PINNACLE DESTINATION PERIPHERAL GUIDING SHEATHK082997TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER

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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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