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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 K971967
Device Name BUN
Applicant
Carolina Liquid Chemistries Corp.
451 W. Lambert Rd.,
Suite 207
Brea,  CA  92821
Applicant Contact CYNTHIA SHUGART
Correspondent
Carolina Liquid Chemistries Corp.
451 W. Lambert Rd.,
Suite 207
Brea,  CA  92821
Correspondent Contact CYNTHIA SHUGART
Regulation Number862.1770
Classification Product Code
CDQ  
Date Received05/28/1997
Decision Date 06/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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