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FDA 510(k)

ORATECT ORAL FLUID DRUG SCREEN DEVICES

K-Number: K103227 · 2012-04-11

ApplicantBranan Medical Corporation
Decision Date2012-04-11
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ORATECT ORAL FLUID DRUG SCREEN DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is Branan Medical Corporation. It received FDA 510(k) clearance on 2012-04-11 under 510(k) number K103227. 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 ORATECT ORAL FLUID DRUG SCREEN DEVICES?

ORATECT ORAL FLUID DRUG SCREEN DEVICES is a medical device that received FDA 510(k) clearance on 2012-04-11. The listed applicant is Branan Medical Corporation. The 510(k) number is K103227.

When did ORATECT ORAL FLUID DRUG SCREEN DEVICES receive FDA 510(k) clearance?

ORATECT ORAL FLUID DRUG SCREEN DEVICES received FDA 510(k) clearance on 2012-04-11, under 510(k) number K103227.

Who is the listed applicant for ORATECT ORAL FLUID DRUG SCREEN DEVICES?

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

What is the FDA product code for ORATECT ORAL FLUID DRUG SCREEN DEVICES?

The FDA product code for ORATECT ORAL FLUID DRUG SCREEN DEVICES is DIO.

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View all 11 devices →

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.

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