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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, C-Peptides Of Proinsulin
510(k) Number K810718
Device Name C-PEPTICE REAGENTS
Applicant
Calbiochem-Behring Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Calbiochem-Behring Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1135
Classification Product Code
JKD  
Date Received03/17/1981
Decision Date 03/31/1981
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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