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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, N. Meningitidis
510(k) Number K822810
Device Name PHADEBACT CSF TEST 20
Applicant
Pharmacia, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Pharmacia, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.3390
Classification Product Code
GTJ  
Date Received09/20/1982
Decision Date 12/30/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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