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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Uric, Uricase (Colorimetric)
510(k) Number K873456
Device Name PARAMAX URIC ACID 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 Number862.1775
Classification Product Code
KNK  
Date Received08/28/1987
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
Predetermined Change
Control Plan Authorized		 No
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