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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calibrator, multi-analyte mixture
510(k) Number K903913
Device Name PARAMAX URINE/CSF CALIBRATOR LEVEL I AND II
Applicant
BAXTER HEALTHCARE CORP.
P.O. BOX 25101
SANTA ANA,  CA  92799
Applicant Contact DANA JONES
Correspondent
BAXTER HEALTHCARE CORP.
P.O. BOX 25101
SANTA ANA,  CA  92799
Correspondent Contact DANA JONES
Regulation Number862.1150
Classification Product Code
JIX  
Date Received08/24/1990
Decision Date 09/27/1990
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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