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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 K850053
Device Name BACI 6 -ADRENOCORTICOTROOP HORMONE
Applicant
Euro-Diagnostics BV
R.W. Greeff & Co.
1445 E. Putnam Ave.
Old Greenwich,  CT  06870
Applicant Contact PAUL M SZUTOWICZ
Correspondent
Euro-Diagnostics BV
R.W. Greeff & Co.
1445 E. Putnam Ave.
Old Greenwich,  CT  06870
Correspondent Contact PAUL M SZUTOWICZ
Regulation Number862.1025
Classification Product Code
CKG  
Date Received01/08/1985
Decision Date 04/08/1985
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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