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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, All Groups, Salmonella Spp.
510(k) Number K890146
Device Name WELLCOLEX COLOUR SALMONELLA TEST ZL 50
Applicant
Wellcome Diagnostics
3030 Cornwallis Rd.
Research Triangle Pk,  NC  27709
Applicant Contact MOODY, PH.D.
Correspondent
Wellcome Diagnostics
3030 Cornwallis Rd.
Research Triangle Pk,  NC  27709
Correspondent Contact MOODY, PH.D.
Regulation Number866.3550
Classification Product Code
GRM  
Date Received01/13/1989
Decision Date 02/16/1989
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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