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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 K002638
Device Name FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT
Applicant
Future Diagnostics B.V.
4079 Mt. Barnard
San Diego,  CA  92111
Applicant Contact DAVE D SMITH
Correspondent
Future Diagnostics B.V.
4079 Mt. Barnard
San Diego,  CA  92111
Correspondent Contact DAVE D SMITH
Regulation Number862.1025
Classification Product Code
CKG  
Date Received08/24/2000
Decision Date 01/17/2001
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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