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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name culture media, selective and differential
510(k) Number K821605
Device Name XYLOSE LYSINE DEOXYCHOLATE AGAR
Applicant
HARDY MEDIA
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
HARDY MEDIA
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number866.2360
Classification Product Code
JSI  
Date Received05/28/1982
Decision Date 07/06/1982
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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