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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Visual, Pregnancy Hcg, Prescription Use
510(k) Number K925125
Device Name PRO-STEP HCG
Applicant
DISEASE DETECTION INTERNATIONAL, INC.
2 THOMAS
IRVINE,  CA  92718
Applicant Contact SIEGFRIED KRUTZIK
Correspondent
DISEASE DETECTION INTERNATIONAL, INC.
2 THOMAS
IRVINE,  CA  92718
Correspondent Contact SIEGFRIED KRUTZIK
Regulation Number862.1155
Classification Product Code
JHI  
Date Received10/13/1992
Decision Date 01/13/1993
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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