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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Estriol
510(k) Number K821678
Device Name AUTOPAK ESTRIOL TEST DELIVERY SYSTEM
Applicant
Micromedic Systems
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Micromedic Systems
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1265
Classification Product Code
CGI  
Date Received06/08/1982
Decision Date 06/24/1982
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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