AT HOME DRUG TEST, MODEL 9063 T— 510(k) K010645

Substantially Equivalent

Phamatech

FDA 510(k) clearance K010645 for AT HOME DRUG TEST, MODEL 9063 T, Substantially Equivalent on 2001-03-30. Applicant: Phamatech. Device class: 2.

Clearance details

Applicant: Phamatech
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2001-03-05
Decision date: 2001-03-30
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Phamatech

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Data sourced from openFDA. This site is unofficial and independent of the FDA.