Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup

K-Number: K162395 · 2017-06-02

ApplicantMp Biomedicals, LLC
Decision Date2017-06-02
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup is the device name listed in this FDA 510(k) record. The listed applicant is Mp Biomedicals, LLC. It received FDA 510(k) clearance on 2017-06-02 under 510(k) number K162395. 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 MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup?

MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup is a medical device that received FDA 510(k) clearance on 2017-06-02. The listed applicant is Mp Biomedicals, LLC. The 510(k) number is K162395.

When did MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup receive FDA 510(k) clearance?

MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup received FDA 510(k) clearance on 2017-06-02, under 510(k) number K162395.

Who is the listed applicant for MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup?

The FDA 510(k) record lists Mp Biomedicals, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup?

The FDA product code for MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup is DIO.

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 CorporationK191638Pointe Scientific Cocaine Metabolite Enzyme ImmunoassayMedtest DXK181499DRI 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 Corporation

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.

↑