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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Primary
510(k) Number K810867
Device Name FOLLICLE STIMULATING HORMONE (FSH)
Applicant
Pcl-Ria, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Pcl-Ria, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1150
Classification Product Code
JIS  
Date Received03/31/1981
Decision Date 04/14/1981
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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