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FDA 510(k)

UBI MAGIWEL CORTISOL QUANTITATIVE

K-Number: K905473 · 1991-01-31

ApplicantUnited Biotech, Inc.
Decision Date1991-01-31
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UBI MAGIWEL CORTISOL 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 1991-01-31 under 510(k) number K905473. The device is classified under product code CGR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UBI MAGIWEL CORTISOL QUANTITATIVE?

UBI MAGIWEL CORTISOL QUANTITATIVE is a medical device that received FDA 510(k) clearance on 1991-01-31. The listed applicant is United Biotech, Inc.. The 510(k) number is K905473.

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

UBI MAGIWEL CORTISOL QUANTITATIVE received FDA 510(k) clearance on 1991-01-31, under 510(k) number K905473.

Who is the listed applicant for UBI MAGIWEL CORTISOL 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 CORTISOL QUANTITATIVE?

The FDA product code for UBI MAGIWEL CORTISOL QUANTITATIVE is CGR.

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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) QUANTITATIVEK973155UBI MAGIWEL OPIATE METABOLITESK973156UBI MAGIWEL COCAINE METABOLITESK973153UBI MAGIWEL AMPHETAMINE METABOLITES

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Related Devices (Code: CGR)

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.

K242190Access Cortisol; DxC 500i Clinical AnalyzerBeckman Coulter, Inc.K223038Access CortisolBeckman Coulter, Inc.K202136IDS CortisolImmunodiagnostic Systems , Ltd.K202826IMMULITE® 2000 CortisolSiemens Healthcare Diagnostics Products, Ltd.K203270IMMULITE/IMMULITE® 1000 CortisolSiemens Healthcare Diagnostics Products, Ltd.K062626CORTISOL ELISAIbl-Hamburg GmbH

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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