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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Allergy & Applicator Depot, LLC. It received FDA 510(k) clearance on 2019-04-10 under 510(k) 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. The listed applicant is Allergy & Applicator Depot, LLC. The 510(k) number is K182582.

When did Oryum and Ovem Epidermal Deri Prick Test Applicator receive FDA 510(k) clearance?

Oryum and Ovem Epidermal Deri Prick Test Applicator received FDA 510(k) clearance on 2019-04-10, under 510(k) number K182582.

Who is the listed applicant for Oryum and Ovem Epidermal Deri Prick Test Applicator?

The FDA 510(k) record lists Allergy & Applicator Depot, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: SCL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250983Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)Asistan MedikalK222385Bifurcated NeedleAnhui Tiankang Medical Technology Co., Ltd.K172062AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test TrayMedscience Science Research Group, Inc.K162917Allerhope Allergy Skin TesterProcare Industrial Co., Limited

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.

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