Oryum and Ovem Epidermal Deri Prick Test Applicator— 510(k) K182582

Name: FDA 510(k) clearance K182582
Creator: U.S. Food and Drug Administration
Published: 2019-04-10

Substantially Equivalent

Allergy & Applicator Depot, LLC

FDA 510(k) clearance K182582 for Oryum and Ovem Epidermal Deri Prick Test Applicator, Substantially Equivalent on 2019-04-10. Applicant: Allergy & Applicator Depot, LLC. Device class: 2.

Clearance details

Applicant: Allergy & Applicator Depot, LLC
Product code: Code SCL
Device class: Class 2
Regulation: 21 CFR 880.5570
Advisory panel: General Hospital
Date received: 2018-09-19
Decision date: 2019-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sound Beach, NY, US

Download summary PDF View on FDA.gov ↗

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