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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 K833156
Device Name QUIDEL HCG ENZYME IMMUNOASSAY KIT
Applicant
QUIDEL CORP.
1730 PENNSYLVANIA AVE., N.W.
WASHINGTON,  DC  20006
Correspondent
QUIDEL CORP.
1730 PENNSYLVANIA AVE., N.W.
WASHINGTON,  DC  20006
Regulation Number862.1155
Classification Product Code
JHJ  
Date Received09/16/1983
Decision Date 11/25/1983
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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