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K Number
K011979
Device Name
ALLERSHARP ALLERGY SKIN TESTER
Manufacturer
HMB MEDICAL CONCEPTS, LTD.
Date Cleared
2001-09-14

(81 days)

Product Code
SCL,LDH
Regulation Number
880.5570
Type
Traditional
Panel
HO
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The device system is used for prick application of allergen extracts in the performance of skin testing.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is an FDA correspondence related to the classification of a medical device (AllerSharp™ Allergy Skin Tester) and does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. Therefore, I cannot generate the requested table and paragraphs based on the given input.

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).