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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 K812288
Device Name HUMAN C-PEPTIDE REAGENTS
Applicant
Immunex Radiochemical Diagnostics
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Immunex Radiochemical Diagnostics
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1135
Classification Product Code
JKD  
Date Received08/13/1981
Decision Date 08/31/1981
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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