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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name test, epithelial ovarian tumor-associated antigen (ca125)
510(k) Number K981297
Device Name IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5
Applicant
DIAGNOSTIC PRODUCTS CORP.
5700 WEST 96TH ST.
LOS ANGELES,  CA  90045 -5597
Applicant Contact EDWARD M LEVINE
Correspondent
DIAGNOSTIC PRODUCTS CORP.
5700 WEST 96TH ST.
LOS ANGELES,  CA  90045 -5597
Correspondent Contact EDWARD M LEVINE
Regulation Number866.6010
Classification Product Code
LTK  
Date Received04/08/1998
Decision Date 09/18/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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