QUICKSCREEN AMPHETINE 500 TEST

FDA 510(k) clearance K131069 · decided 2014-05-14

Clearance details

K-number: K131069
Device name: QUICKSCREEN AMPHETINE 500 TEST
Applicant: Phamatech, Inc.
Decision: Substantially Equivalent
Date received: 2013-04-17
Decision date: 2014-05-14
Days to decision: 392 days
Clearance type: Traditional
Product code: DKZ
Device class: 2
Regulation number: 862.3100
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.