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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Luteinizing Hormone
510(k) Number K943252
Device Name PRO-STEP LH OVULATION PREDICTION TEST
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 Number862.1485
Classification Product Code
CEP  
Date Received07/06/1994
Decision Date 10/25/1994
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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