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FDA 510(k)

UBI MAGIWEL COCAINE METABOLITES

K-Number: K973156 · 1997-10-28

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

Device Summary

UBI MAGIWEL COCAINE 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 K973156. 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 COCAINE METABOLITES?

UBI MAGIWEL COCAINE 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 K973156.

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

UBI MAGIWEL COCAINE METABOLITES received FDA 510(k) clearance on 1997-10-28, under 510(k) number K973156.

Who is the listed applicant for UBI MAGIWEL COCAINE 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 COCAINE METABOLITES?

The FDA product code for UBI MAGIWEL COCAINE 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) QUANTITATIVEK973155UBI MAGIWEL OPIATE METABOLITESK973153UBI MAGIWEL AMPHETAMINE 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.

K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc.K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories LimitedK253082LZI Buprenorphine II Enzyme ImmunoassayLin-Zhi International, Inc.K252520SEFRIA™ Hydrocodone Oral FluidImmunalysis CorporationK251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)Healgen Scientific,, LLCK251634LZI Fentanyl III Enzyme ImmunoassayLin-Zhi International, 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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