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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Conjugated Fluorescent, Cytomegalovirus
510(k) Number K983762
Device Name NUCLISENS CMV PP67
Applicant
ORGANON TEKNIKA CORP.
100 AKZO AVE.
DURHAM,  NC  27712
Applicant Contact RON SANYAL
Correspondent
ORGANON TEKNIKA CORP.
100 AKZO AVE.
DURHAM,  NC  27712
Correspondent Contact RON SANYAL
Regulation Number866.3175
Classification Product Code
LIN  
Date Received10/26/1998
Decision Date 09/15/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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