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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 K822578
Device Name MICROMEDIC ESTRIOL RIA KIT
Applicant
Micromedic Systems
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Micromedic Systems
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1265
Classification Product Code
CGI  
Date Received08/25/1982
Decision Date 10/26/1982
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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