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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Human Growth Hormone
510(k) Number K921868
Device Name ENDOCRINE SCIENCES PRODUCTS IGFBP3 RADIOIMMUNO KIT
Applicant
Endocrine Sciences Products
4301 Lost Hills Rd.
Calabasas,  CA  91301
Applicant Contact WALT CHANDLER
Correspondent
Endocrine Sciences Products
4301 Lost Hills Rd.
Calabasas,  CA  91301
Correspondent Contact WALT CHANDLER
Regulation Number862.1370
Classification Product Code
CFL  
Date Received04/20/1992
Decision Date 01/03/1994
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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