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FDA 510(k)

Allerhope Allergy Skin Tester

K-Number: K162917 · 2017-08-17

ApplicantProcare Industrial Co., Limited
Decision Date2017-08-17
Product CodeSCL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Allerhope Allergy Skin Tester is the device name listed in this FDA 510(k) record. The listed applicant is Procare Industrial Co., Limited. It received FDA 510(k) clearance on 2017-08-17 under 510(k) number K162917. 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 Allerhope Allergy Skin Tester?

Allerhope Allergy Skin Tester is a medical device that received FDA 510(k) clearance on 2017-08-17. The listed applicant is Procare Industrial Co., Limited. The 510(k) number is K162917.

When did Allerhope Allergy Skin Tester receive FDA 510(k) clearance?

Allerhope Allergy Skin Tester received FDA 510(k) clearance on 2017-08-17, under 510(k) number K162917.

Who is the listed applicant for Allerhope Allergy Skin Tester?

The FDA 510(k) record lists Procare Industrial Co., Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Allerhope Allergy Skin Tester?

The FDA product code for Allerhope Allergy Skin Tester 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.K182582Oryum and Ovem Epidermal Deri Prick Test ApplicatorAllergy & Applicator Depot, LLCK172062AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test TrayMedscience Science Research Group, Inc.

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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