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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioassay, Angiotensin Converting Enzyme
510(k) Number K833933
Device Name ACE COLOR TEST
Applicant
Hana Biologics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Hana Biologics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1090
Classification Product Code
KQN  
Date Received11/14/1983
Decision Date 03/23/1984
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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