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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bromcresol Green Dye-Binding, Albumin
510(k) Number K780092
Device Name ULTRACHEM ALBUMIN
Applicant
Harleco
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Harleco
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1035
Classification Product Code
CIX  
Date Received01/18/1978
Decision Date 02/07/1978
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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