Atlas FDA

FIRST CHECK MULTI DRUG CUP 7 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY

FDA 510(k) clearance K051966 · decided 2005-09-07

Clearance details

K-number
K051966
Device name
FIRST CHECK MULTI DRUG CUP 7 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY
Applicant
Worldwide Medical, LLC
Decision
Substantially Equivalent
Date received
2005-07-20
Decision date
2005-09-07
Days to decision
49 days
Clearance type
Traditional
Product code
DKZ
Device class
2
Regulation number
862.3100
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Lake Forest, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.