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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name berthelot indophenol, urea nitrogen
510(k) Number K864742
Device Name UREA NITROGEN(BUN), COLORIMETRIC METHOD
Applicant
TECH-CO, INC.
4378 REILLY
TROY,  MI  48098
Applicant Contact HAPPY CHEN
Correspondent
TECH-CO, INC.
4378 REILLY
TROY,  MI  48098
Correspondent Contact HAPPY CHEN
Regulation Number862.1770
Classification Product Code
CDL  
Date Received12/04/1986
Decision Date 01/13/1987
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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