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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Calcitonin
510(k) Number K912536
Device Name CALCITONIN KIT MITSUBISHI YUKA
Applicant
Mitsubishi Yuka America, Inc.
1625 K St. NW
Suite 1000
Washington,  DC  20006
Applicant Contact MICHAEL G FARROW
Correspondent
Mitsubishi Yuka America, Inc.
1625 K St. NW
Suite 1000
Washington,  DC  20006
Correspondent Contact MICHAEL G FARROW
Regulation Number862.1140
Classification Product Code
JKR  
Date Received06/07/1991
Decision Date 07/18/1991
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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