Oryum and Ovem Epidermal Deri Prick Test Applicator
K-Number: K182582 · 2019-04-10
ApplicantAllergy & Applicator Depot, LLC
Decision Date2019-04-10
Product CodeSCL
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Oryum and Ovem Epidermal Deri Prick Test Applicator is a medical device manufactured by Allergy & Applicator Depot, LLC. It received FDA 510(k) clearance on 2019-04-10 under approval number K182582. The device is classified under product code SCL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Oryum and Ovem Epidermal Deri Prick Test Applicator?
Oryum and Ovem Epidermal Deri Prick Test Applicator is a medical device that received FDA 510(k) clearance on 2019-04-10. It is manufactured by Allergy & Applicator Depot, LLC. The 510(k) number is K182582.
When was Oryum and Ovem Epidermal Deri Prick Test Applicator approved by the FDA?
Oryum and Ovem Epidermal Deri Prick Test Applicator received FDA 510(k) clearance on 2019-04-10, under approval number K182582.
What company makes Oryum and Ovem Epidermal Deri Prick Test Applicator?
Oryum and Ovem Epidermal Deri Prick Test Applicator is manufactured by Allergy & Applicator Depot, LLC.
What is the FDA product code for Oryum and Ovem Epidermal Deri Prick Test Applicator?
The FDA product code for Oryum and Ovem Epidermal Deri Prick Test Applicator is SCL.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.