Atlas FDA

QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225

FDA 510(k) clearance K000447 · decided 2000-03-07

Clearance details

K-number
K000447
Device name
QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225
Applicant
Phamatech
Decision
Substantially Equivalent
Date received
2000-02-10
Decision date
2000-03-07
Days to decision
26 days
Clearance type
Special
Product code
LAF
Device class
2
Regulation number
862.3610
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
San Diego, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.