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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Prolactin (Lactogen)
510(k) Number K810949
Device Name MRI PROLACTIN RIA KIT
Applicant
Microanalytic Research, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Microanalytic Research, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1625
Classification Product Code
CFT  
Date Received04/07/1981
Decision Date 07/10/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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