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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 Types, Streptococcus Pneumoniae
510(k) Number K841376
Device Name WELLCOGEN S. PNEUMONIAE
Applicant
Wellcome Diagnostics
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Wellcome Diagnostics
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.3740
Classification Product Code
GWC  
Date Received04/03/1984
Decision Date 05/02/1984
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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