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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spatula, Cervical, Cytological
510(k) Number K013258
Device Name INPATH E2 COLLECTOR
Applicant
Molecular Diagnostics
414 N. Orleans
Suite 510
Chicago,  IL  60610
Applicant Contact ROBERT L HABIG
Correspondent
Molecular Diagnostics
414 N. Orleans
Suite 510
Chicago,  IL  60610
Correspondent Contact ROBERT L HABIG
Regulation Number884.4530
Classification Product Code
HHT  
Date Received10/01/2001
Decision Date 05/31/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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