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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiometric, Fe59, Iron Binding Capacity
510(k) Number K780412
Device Name TOTAL IRON BINDING CAPACITY
Applicant
Diagnostic Corp. of America
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Diagnostic Corp. of America
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1415
Classification Product Code
JQG  
Date Received03/15/1978
Decision Date 05/26/1978
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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