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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Iga, Antigen, Antiserum, Control
510(k) Number K790703
Device Name ANTISERUM, HUMAN, IGA
Applicant
Kent Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Kent Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.5510
Classification Product Code
CZP  
Date Received04/12/1979
Decision Date 04/12/1979
Decision SE - Postmarket Surveillance Required (SESP)
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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