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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Exoenzymes, Multiple, Streptococcal
510(k) Number K822799
Device Name STREPTACOCCUS CO-AGGLUTINATION KIT
Applicant
American Scientific Products
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
American Scientific Products
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.3720
Classification Product Code
GTP  
Date Received09/16/1982
Decision Date 12/19/1982
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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