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FDA 510(k)

UBI MAGIWEL(TM) TSH QUANTITATIVE

K-Number: K864079 · 1986-12-16

ApplicantUnited Biotech, Inc.
Decision Date1986-12-16
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UBI MAGIWEL(TM) TSH 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 1986-12-16 under 510(k) number K864079. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UBI MAGIWEL(TM) TSH QUANTITATIVE?

UBI MAGIWEL(TM) TSH QUANTITATIVE is a medical device that received FDA 510(k) clearance on 1986-12-16. The listed applicant is United Biotech, Inc.. The 510(k) number is K864079.

When did UBI MAGIWEL(TM) TSH QUANTITATIVE receive FDA 510(k) clearance?

UBI MAGIWEL(TM) TSH QUANTITATIVE received FDA 510(k) clearance on 1986-12-16, under 510(k) number K864079.

Who is the listed applicant for UBI MAGIWEL(TM) TSH 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(TM) TSH QUANTITATIVE?

The FDA product code for UBI MAGIWEL(TM) TSH QUANTITATIVE is JLW.

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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) QUANTITATIVEK973153UBI MAGIWEL AMPHETAMINE METABOLITESK973156UBI MAGIWEL COCAINE METABOLITESK973155UBI MAGIWEL OPIATE METABOLITES

View all 22 devices →

Related Devices (Code: JLW)

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.

K251543Atellica® IM TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.K243570Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)Siemens Healthcare DiagnosticsK234091Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0Genalyte, Inc.K233050ADVIA Centaur® TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.K222116Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)Siemens Healthcare Diagnostics, Inc.K221225Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay AnalyzerBeckman 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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