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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pneumocystis Carinii
510(k) Number K905504
Device Name STAINING SYSTEM FOR PNEUMOCYSTIS CARINII
Applicant
Dako Corp.
6392 Via Real
Carpinteria,  CA  93013
Applicant Contact DEBORA D HINMAN
Correspondent
Dako Corp.
6392 Via Real
Carpinteria,  CA  93013
Correspondent Contact DEBORA D HINMAN
Regulation Number866.3780
Classification Product Code
LYF  
Date Received12/07/1990
Decision Date 06/28/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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