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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Uric, Uricase (U.V.)
510(k) Number K821465
Device Name ULTRACHEM URIC ACID AIDH, #65047
Applicant
Emd Chemicals, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Emd Chemicals, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1775
Classification Product Code
CDO  
Date Received05/18/1982
Decision Date 06/02/1982
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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