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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control
510(k) Number K823765
Device Name ANTI SERA TO HUMAN OROSCOMUCOID
Applicant
Kent Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Kent Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.5420
Classification Product Code
DEX  
Date Received12/14/1982
Decision Date 12/30/1982
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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