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FDA 510(k)

UBI MAGIWEL AMPHETAMINE METABOLITES

K-Number: K973153 · 1997-10-28

ApplicantUnited Biotech, Inc.
Decision Date1997-10-28
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

UBI MAGIWEL AMPHETAMINE METABOLITES 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 1997-10-28 under 510(k) number K973153. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UBI MAGIWEL AMPHETAMINE METABOLITES?

UBI MAGIWEL AMPHETAMINE METABOLITES is a medical device that received FDA 510(k) clearance on 1997-10-28. The listed applicant is United Biotech, Inc.. The 510(k) number is K973153.

When did UBI MAGIWEL AMPHETAMINE METABOLITES receive FDA 510(k) clearance?

UBI MAGIWEL AMPHETAMINE METABOLITES received FDA 510(k) clearance on 1997-10-28, under 510(k) number K973153.

Who is the listed applicant for UBI MAGIWEL AMPHETAMINE METABOLITES?

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 AMPHETAMINE METABOLITES?

The FDA product code for UBI MAGIWEL AMPHETAMINE METABOLITES is DJG.

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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 METABOLITESK962211UBI MAGIWEL THYROXINE (T4) QUANTITATIVE

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Related Devices (Code: DJG)

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.

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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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