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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, human chorionic gonadotropin
510(k) Number K033234
Device Name IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER
Applicant
DIAGNOSTIC PRODUCTS CORP.
5700 WEST 96TH ST.
LOS ANGELES,  CA  90045 -5597
Applicant Contact EDWARD LEVINE
Correspondent
DIAGNOSTIC PRODUCTS CORP.
5700 WEST 96TH ST.
LOS ANGELES,  CA  90045 -5597
Correspondent Contact EDWARD LEVINE
Regulation Number862.1155
Classification Product Code
DHA  
Subsequent Product Codes
JJE   JLW  
Date Received10/06/2003
Decision Date 12/12/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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