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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name kit, screening, yeast
510(k) Number K891476
Device Name C. ALBICANS SCREEN
Applicant
CARR-SCARBOROUGH MICROBIOLOGICALS, INC.
P.O. BOX 1328
STONE MOUNTAIN,  GA  30086
Applicant Contact C SCARBOROUGH
Correspondent
CARR-SCARBOROUGH MICROBIOLOGICALS, INC.
P.O. BOX 1328
STONE MOUNTAIN,  GA  30086
Correspondent Contact C SCARBOROUGH
Regulation Number866.2660
Classification Product Code
JXC  
Date Received03/16/1989
Decision Date 04/12/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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