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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Acth
510(k) Number K910178
Device Name ACTH IRMA KIT MITSUBISHI YUKA
Applicant
Science Regulatory Services Intl.
Suite 975
1625 K St., NW
Washington,  DC  20006
Applicant Contact MICHAEL G FARROW
Correspondent
Science Regulatory Services Intl.
Suite 975
1625 K St., NW
Washington,  DC  20006
Correspondent Contact MICHAEL G FARROW
Regulation Number862.1025
Classification Product Code
CKG  
Date Received01/15/1991
Decision Date 05/22/1991
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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