ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device— 510(k) K191807

Name: FDA 510(k) clearance K191807
Creator: U.S. Food and Drug Administration
Published: 2019-10-25

Substantially Equivalent

ALPCO

FDA 510(k) clearance K191807 for ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device, Substantially Equivalent on 2019-10-25. Applicant: ALPCO. Device class: 2.

Clearance details

Applicant: ALPCO
Product code: Code NXO
Device class: Class 2
Regulation: 21 CFR 866.5180
Advisory panel: Immunology
Date received: 2019-07-05
Decision date: 2019-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salem, NH, US

Download summary PDF View on FDA.gov ↗

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