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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name kit, test, pregnancy, hcg, over the counter
510(k) Number K772359
Device Name PREGNANCY TEST KIT, ANSWER
Applicant
DIAGNOSTIC TESTING, INC.
MD 
Correspondent
DIAGNOSTIC TESTING, INC.
MD 
Regulation Number862.1155
Classification Product Code
LCX  
Date Received12/27/1977
Decision Date 01/05/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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