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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 K060548
Device Name STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAK
Applicant
DADE BEHRING, INC.
GLASGOW BUSINESS COMMUNITY
BLDG 500, MS 514 P.O.BOX 6101
NEWARK,  DE  19714 -6101
Applicant Contact PAMELA A JURGA
Correspondent
DADE BEHRING, INC.
GLASGOW BUSINESS COMMUNITY
BLDG 500, MS 514 P.O.BOX 6101
NEWARK,  DE  19714 -6101
Correspondent Contact PAMELA A JURGA
Regulation Number862.1155
Classification Product Code
DHA  
Subsequent Product Codes
JIT   NBC  
Date Received03/01/2006
Decision Date 04/06/2006
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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