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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 K926396
Device Name ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT
Applicant
Nichols Institute
33608 Ortega Hwy.
San Juan Capistrano,  CA  92690
Applicant Contact SALVADORE PALOMARES
Correspondent
Nichols Institute
33608 Ortega Hwy.
San Juan Capistrano,  CA  92690
Correspondent Contact SALVADORE PALOMARES
Regulation Number862.1025
Classification Product Code
CKG  
Date Received12/21/1992
Decision Date 07/27/1993
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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