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FDA 510(k)

Pointe Scientific Cocaine Metabolite Enzyme Immunoassay

K-Number: K191638 · 2020-03-12

ApplicantMedtest DX
Decision Date2020-03-12
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Pointe Scientific Cocaine Metabolite Enzyme Immunoassay is the device name listed in this FDA 510(k) record. The listed applicant is Medtest DX. It received FDA 510(k) clearance on 2020-03-12 under 510(k) number K191638. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pointe Scientific Cocaine Metabolite Enzyme Immunoassay?

Pointe Scientific Cocaine Metabolite Enzyme Immunoassay is a medical device that received FDA 510(k) clearance on 2020-03-12. The listed applicant is Medtest DX. The 510(k) number is K191638.

When did Pointe Scientific Cocaine Metabolite Enzyme Immunoassay receive FDA 510(k) clearance?

Pointe Scientific Cocaine Metabolite Enzyme Immunoassay received FDA 510(k) clearance on 2020-03-12, under 510(k) number K191638.

Who is the listed applicant for Pointe Scientific Cocaine Metabolite Enzyme Immunoassay?

The FDA 510(k) record lists Medtest DX as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pointe Scientific Cocaine Metabolite Enzyme Immunoassay?

The FDA product code for Pointe Scientific Cocaine Metabolite Enzyme Immunoassay is DIO.

Other records listing Medtest DX 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.

K191296Pointe Scientific Creatinine Kinase (CK) Reagent Set

Related Devices (Code: DIO)

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.

K213211Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test SystemCarolina Liquid Chemistries Corp.K211973DRI Cocaine Metabolite AssayMicrogenics CorporationK181499DRI Cocaine Metabolite AssayMicrogenics CorporationK170293Emit II Plus Cocaine Metabolite AssaySiemens Healthcare Diagnostics, Inc.K163570Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)Carolina Liquid Chemistries CorporationK162395MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test CupMp Biomedicals, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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