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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 K883430
Device Name PREGNA-CARD(TM) A VISUAL HOME PREGNANCY TEST
Applicant
Disease Detection International, Inc.
17935 Sky Park Cir., Suite
D
Irvine,  CA  92714
Applicant Contact SIEGFRIED KRUTZIK
Correspondent
Disease Detection International, Inc.
17935 Sky Park Cir., Suite
D
Irvine,  CA  92714
Correspondent Contact SIEGFRIED KRUTZIK
Regulation Number862.1155
Classification Product Code
LCX  
Date Received08/15/1988
Decision Date 01/30/1989
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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