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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diacetyl-Monoxime, Urea Nitrogen
510(k) Number K800673
Device Name SMAC REPLACEMENT REAGENTS/OF BUN-SERUM
Applicant
DIAGNOSTIC SOLUTIONS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
DIAGNOSTIC SOLUTIONS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1770
Classification Product Code
CDW  
Date Received03/26/1980
Decision Date 05/28/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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