QUICKSCREEN PRO DRUG CUP, MODEL 9195X— 510(k) K001397

Name: FDA 510(k) clearance K001397
Creator: U.S. Food and Drug Administration
Published: 2000-05-26

Substantially Equivalent

Phamatech

FDA 510(k) clearance K001397 for QUICKSCREEN PRO DRUG CUP, MODEL 9195X, Substantially Equivalent on 2000-05-26. 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: 2000-05-03
Decision date: 2000-05-26
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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