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FDA 510(k)

UBI MAGIWEL THYROXINE (T4) QUANTITATIVE

K-Number: K962211 · 1996-07-08

ApplicantUnited Biotech, Inc.
Decision Date1996-07-08
Product CodeKLI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UBI MAGIWEL THYROXINE (T4) QUANTITATIVE is the device name listed in this FDA 510(k) record. The listed applicant is United Biotech, Inc.. It received FDA 510(k) clearance on 1996-07-08 under 510(k) number K962211. 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 UBI MAGIWEL THYROXINE (T4) QUANTITATIVE?

UBI MAGIWEL THYROXINE (T4) QUANTITATIVE is a medical device that received FDA 510(k) clearance on 1996-07-08. The listed applicant is United Biotech, Inc.. The 510(k) number is K962211.

When did UBI MAGIWEL THYROXINE (T4) QUANTITATIVE receive FDA 510(k) clearance?

UBI MAGIWEL THYROXINE (T4) QUANTITATIVE received FDA 510(k) clearance on 1996-07-08, under 510(k) number K962211.

Who is the listed applicant for UBI MAGIWEL THYROXINE (T4) QUANTITATIVE?

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

What is the FDA product code for UBI MAGIWEL THYROXINE (T4) QUANTITATIVE?

The FDA product code for UBI MAGIWEL THYROXINE (T4) QUANTITATIVE is KLI.

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Other records listing United Biotech, 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.

K981573UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVEK973154UBI MAGIWEL MARIJUANA METABOLITESK973692UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVEK973156UBI MAGIWEL COCAINE METABOLITESK973155UBI MAGIWEL OPIATE METABOLITESK973153UBI MAGIWEL AMPHETAMINE METABOLITES

View all 22 devices →

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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