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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ceruloplasmin, Antigen, Antiserum, Control
510(k) Number K772255
Device Name CERULOPLASMIN NEPHEL. ASSAY
Applicant
Kallestad Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Kallestad Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.5210
Classification Product Code
DDB  
Date Received12/09/1977
Decision Date 01/05/1978
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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