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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 K873532
Device Name PARAMAX UREA NITROGEN REAGENT
Applicant
BAXTER HEALTHCARE CORP.
P.O. BOX 25101
SANTA ANA,  CA  92799
Applicant Contact KRISTA SMALLEY
Correspondent
BAXTER HEALTHCARE CORP.
P.O. BOX 25101
SANTA ANA,  CA  92799
Correspondent Contact KRISTA SMALLEY
Regulation Number862.1770
Classification Product Code
CDQ  
Date Received09/01/1987
Decision Date 11/23/1987
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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