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FDA 510(k)

UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE

K-Number: K961236 · 1996-05-30

ApplicantUnited Biotech, Inc.
Decision Date1996-05-30
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UBI MAGIWEL TRIIODOTHYRONINE(T3) 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 1996-05-30 under 510(k) number K961236. 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 UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE?

UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE is a medical device that received FDA 510(k) clearance on 1996-05-30. The listed applicant is United Biotech, Inc.. The 510(k) number is K961236.

When did UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE receive FDA 510(k) clearance?

UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE received FDA 510(k) clearance on 1996-05-30, under 510(k) number K961236.

Who is the listed applicant for UBI MAGIWEL TRIIODOTHYRONINE(T3) 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 TRIIODOTHYRONINE(T3) QUANTITATIVE?

The FDA product code for UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE is CDP.

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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: 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

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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