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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ige, Antigen, Antiserum, Control
510(k) Number K841824
Device Name PHARMACIA IGE RIA
Applicant
Pharmacia, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Pharmacia, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.5510
Classification Product Code
DGC  
Date Received05/02/1984
Decision Date 06/07/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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