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510(k) Data Aggregation
K Number
K162917Device Name
Allerhope Allergy Skin Tester
Manufacturer
PROCARE INDUSTRIAL CO., LIMITED
Date Cleared
2017-08-17
(303 days)
Product Code
SCL, LDH
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
PROCARE INDUSTRIAL CO., LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Allerhope® Allergy Skin Tester is for the percutaneous administration of diagnostic allergenic extracts.
Device Description
Allerhope Allergy skin tester is a sterile, disposable, multiple test head applicator used to administer skin test substances. When used to apply allergenic extracts it provides a quick, convenient, and standardized procedure.
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