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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, Single Biochemical Test
510(k) Number K842853
Device Name LYSINE IRON AGAR
Applicant
Anarobe Systems
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Anarobe Systems
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.2320
Classification Product Code
JSF  
Date Received07/20/1984
Decision Date 08/03/1984
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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