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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name discs, strips and reagents, microorganism differentiation
510(k) Number K842828
Device Name STREPTEX ZL01
Applicant
WELLCOME DIAGNOSTICS
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
WELLCOME DIAGNOSTICS
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number866.2660
Classification Product Code
JTO  
Date Received07/20/1984
Decision Date 08/15/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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