Atlas FDA

MEDTOXSCAN

FDA 510(k) clearance K080635 · decided 2009-02-13

Clearance details

K-number
K080635
Device name
MEDTOXSCAN
Applicant
Medtox Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2008-03-06
Decision date
2009-02-13
Days to decision
344 days
Clearance type
Traditional
Product code
DKZ
Device class
2
Regulation number
862.3100
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Burlington, NC, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitative detection of d recall (Z-1329-2013)Medtox Diagnostics Inc2013-05-16