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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Radioallergosorbent (Rast) Immunological
510(k) Number K013134
Device Name IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS)
Applicant
DIAGNOSTIC PRODUCTS CORP.
5700 WEST 96TH ST.
LOS ANGELES,  CA  90045 -5597
Applicant Contact EDWARDS M LEVINE
Correspondent
DIAGNOSTIC PRODUCTS CORP.
5700 WEST 96TH ST.
LOS ANGELES,  CA  90045 -5597
Correspondent Contact EDWARDS M LEVINE
Regulation Number866.5750
Classification Product Code
DHB  
Date Received09/19/2001
Decision Date 10/15/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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