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FDA 510(k)

ALLERSHARP ALLERGY SKIN TESTER

K-Number: K011979 · 2001-09-14

ApplicantHmb Medical Concepts, Ltd.
Decision Date2001-09-14
Product CodeSCL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ALLERSHARP ALLERGY SKIN TESTER is the device name listed in this FDA 510(k) record. The listed applicant is Hmb Medical Concepts, Ltd.. It received FDA 510(k) clearance on 2001-09-14 under 510(k) number K011979. 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 ALLERSHARP ALLERGY SKIN TESTER?

ALLERSHARP ALLERGY SKIN TESTER is a medical device that received FDA 510(k) clearance on 2001-09-14. The listed applicant is Hmb Medical Concepts, Ltd.. The 510(k) number is K011979.

When did ALLERSHARP ALLERGY SKIN TESTER receive FDA 510(k) clearance?

ALLERSHARP ALLERGY SKIN TESTER received FDA 510(k) clearance on 2001-09-14, under 510(k) number K011979.

Who is the listed applicant for ALLERSHARP ALLERGY SKIN TESTER?

The FDA 510(k) record lists Hmb Medical Concepts, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALLERSHARP ALLERGY SKIN TESTER?

The FDA product code for ALLERSHARP ALLERGY SKIN TESTER is SCL.

Related Clinical Trials

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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.K162917Allerhope Allergy Skin TesterProcare Industrial Co., LimitedK032528BD ECLIPSE BIFURCATED NEEDLEBecton, Dickinson & CO

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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