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FDA 510(k)

AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray

K-Number: K172062 · 2018-03-05

ApplicantMedscience Science Research Group, Inc.
Decision Date2018-03-05
Product CodeSCL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray is the device name listed in this FDA 510(k) record. The listed applicant is Medscience Science Research Group, Inc.. It received FDA 510(k) clearance on 2018-03-05 under 510(k) number K172062. 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 AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray?

AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray is a medical device that received FDA 510(k) clearance on 2018-03-05. The listed applicant is Medscience Science Research Group, Inc.. The 510(k) number is K172062.

When did AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray receive FDA 510(k) clearance?

AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray received FDA 510(k) clearance on 2018-03-05, under 510(k) number K172062.

Who is the listed applicant for AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray?

The FDA 510(k) record lists Medscience Science Research Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray?

The FDA product code for AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray 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, LLCK162917Allerhope 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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