Atlas FDA

PSYCHEMEDICS METHAMPHETAMINE EIA

FDA 510(k) clearance K111927 · decided 2012-05-01

Clearance details

K-number
K111927
Device name
PSYCHEMEDICS METHAMPHETAMINE EIA
Applicant
Psychemedics Corp.
Decision
Substantially Equivalent
Date received
2011-07-06
Decision date
2012-05-01
Days to decision
300 days
Clearance type
Traditional
Product code
LAF
Device class
2
Regulation number
862.3610
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Culver City, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.