Quantisal Oral Fluid Collection Device— 510(k) K200801

Name: FDA 510(k) clearance K200801
Creator: U.S. Food and Drug Administration
Published: 2020-07-28

Substantially Equivalent

Immunalysis Corporation

FDA 510(k) clearance K200801 for Quantisal Oral Fluid Collection Device, Substantially Equivalent on 2020-07-28. Applicant: Immunalysis Corporation. Device class: 2.

Clearance details

Applicant: Immunalysis Corporation
Product code: Code PJD
Device class: Class 2
Regulation: 21 CFR 862.1675
Advisory panel: Clinical Chemistry
Date received: 2020-03-27
Decision date: 2020-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pomona, CA, US

Download summary PDF View on FDA.gov ↗

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