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FDA 510(k)

QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE

K-Number: K130213 · 2013-10-18

ApplicantLumiquick Diagnostics, Inc.
Decision Date2013-10-18
Product CodeLDJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Lumiquick Diagnostics, Inc.. It received FDA 510(k) clearance on 2013-10-18 under 510(k) number K130213. The device is classified under product code LDJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE?

QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE is a medical device that received FDA 510(k) clearance on 2013-10-18. The listed applicant is Lumiquick Diagnostics, Inc.. The 510(k) number is K130213.

When did QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE receive FDA 510(k) clearance?

QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE received FDA 510(k) clearance on 2013-10-18, under 510(k) number K130213.

Who is the listed applicant for QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE?

The FDA 510(k) record lists Lumiquick Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE?

The FDA product code for QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE is LDJ.

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Official Source

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