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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name urease and glutamic dehydrogenase, urea nitrogen
510(k) Number K880078
Device Name UREA NITROGEN (BUN)
Applicant
TECH-NEAL SCIENTIFIC, INC.
817 OAKWOOD DR.
WESTMONT,  IL  60559
Applicant Contact ARUN SANGHAVI
Correspondent
TECH-NEAL SCIENTIFIC, INC.
817 OAKWOOD DR.
WESTMONT,  IL  60559
Correspondent Contact ARUN SANGHAVI
Regulation Number862.1770
Classification Product Code
CDQ  
Date Received01/11/1988
Decision Date 02/11/1988
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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