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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apolipoproteins
510(k) Number K881433
Device Name HEART CHECK APOLIPOPROTEIN-B
Applicant
Northwest Biotech
525 S. River Rd.
P.O. Box 921
Cottage Grove,  OR  97424
Applicant Contact HOWARD H HSY
Correspondent
Northwest Biotech
525 S. River Rd.
P.O. Box 921
Cottage Grove,  OR  97424
Correspondent Contact HOWARD H HSY
Regulation Number862.1475
Classification Product Code
MSJ  
Date Received04/05/1988
Decision Date 04/21/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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