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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Carcinoembryonic Antigen
510(k) Number K833318
Device Name NORMAL GOAT SERUM
Applicant
Biosan Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Biosan Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.6010
Classification Product Code
DHX  
Date Received09/26/1983
Decision Date 01/03/1984
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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