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Found 5 results
510(k) Data Aggregation
K Number
K123184Device Name
FINN CHAMBERS AQUA
Manufacturer
SMART PRACTICE
Date Cleared
2012-12-19
(70 days)
Product Code
KXF, LDH
Regulation Number
880.6025Why did this record match?
Product Code :
KXF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Finn Chambers AQUA is a patch test delivery system and holding device to place allergens and allergen mixes in contact with the surface of the skin during allergen patch tests. Finn Chambers AQUA patch test chambers are intended for use by, or under the supervision of, a physician for use as a patch test diagnostic device used in the testing of individuals suspected of having allergic or irritant contact dermatitis, photocontact dermatitis and experimental skin testing and allergy protocols.
Device Description
Not Found
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K Number
K103409Device Name
ALLERGEAZE R CLEAR
Manufacturer
SMARTPRACTICE
Date Cleared
2011-03-15
(113 days)
Product Code
KXF, LDH
Regulation Number
880.6025Why did this record match?
Product Code :
KXF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
allergEAZE clear Patch Test Chambers are an allergen delivery system which provides a means to place allergens or allergen mixes in contact with the surface of the skin. allergEAZE clear Patch Test Chambers are a intended for use by, or under the supervision of, a physician as a patch test diagnostic device used in the testing of individuals suspected of having allergic or irritant contact dermatitis.
Device Description
Not Found
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K Number
K063160Device Name
ALLERGEAZE PATCH TEST CHAMBERS
Manufacturer
SMART PRACTICE
Date Cleared
2006-12-22
(66 days)
Product Code
KXF, LDH
Regulation Number
880.6025Why did this record match?
Product Code :
KXF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Allergen delivery system which provides a means to place allergens or allergen mixes in contact with the surface of the skin
Device Description
Not Found
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K Number
K013820Device Name
FINN CHAMBER (R)
Manufacturer
EPITEST LTD. OY
Date Cleared
2002-01-30
(75 days)
Product Code
KXF, LDH
Regulation Number
880.6025Why did this record match?
Product Code :
KXF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Finn Chamber® is an aluminum holding device to place allergens and allergen mixes in contact with the surface of skin during allergen patch testing. This product is intended for use by or under the supervision of a physician in the testing of individuals suspected of having allergies. It is not intended for over-thecounter use.
Device Description
Finn Chamber® is an aluminum holding device to place allergens and allergen mixes in contact with the surface of skin during allergen patch testing.
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K Number
K992553Device Name
IQ CHAMBERS
Manufacturer
DORMER LABORATORIES, INC.
Date Cleared
2000-04-12
(257 days)
Product Code
KXF, LDH
Regulation Number
880.6025Why did this record match?
Product Code :
KXF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IQ Chamber is an allergen delivery system which places allergens or allergen mixes in contact with the surface of the skin for the purpose of performing patch testing.
Device Description
The product is a plastic tray with shallow indentations or chambers for use as a place allergens or allergen mixes in contact with the surface of the skin during allergen patch tests.
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