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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agglutination Method, Human Chorionic Gonadotropin
510(k) Number K881435
Device Name PREGNOSPIA II
Applicant
Organon Teknika Corp.
800 Capitola Dr.
Durham,  NC  27713
Applicant Contact SHELDON MAZURSKY
Correspondent
Organon Teknika Corp.
800 Capitola Dr.
Durham,  NC  27713
Correspondent Contact SHELDON MAZURSKY
Regulation Number862.1155
Classification Product Code
JHJ  
Date Received04/05/1988
Decision Date 05/27/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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