QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080)— 510(k) K972619

Name: FDA 510(k) clearance K972619
Creator: U.S. Food and Drug Administration
Published: 1997-08-20

Substantially Equivalent

Phamatech

FDA 510(k) clearance K972619 for QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080), Substantially Equivalent on 1997-08-20. Applicant: Phamatech. Device class: 2.

Clearance details

Applicant: Phamatech
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 1997-07-11
Decision date: 1997-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sandiego, CA, US

Download summary PDF View on FDA.gov ↗

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