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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 K771259
Device Name ALBUMIN TEST, HMA ALBUMIN TEST
Applicant
Hycel, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Hycel, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1035
Classification Product Code
CIX  
Date Received07/11/1977
Decision Date 08/22/1977
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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