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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alkaline Picrate, Colorimetry, Creatinine
510(k) Number K873531
Device Name PARAMAX CREATININE 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 Number862.1225
Classification Product Code
CGX  
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
Predetermined Change
Control Plan Authorized		 No
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