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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 K874587
Device Name PARAMAX URINE/CSF CALIBRATOR
Applicant
BAXTER HEALTHCARE CORP.
P.O. BOX 25101
SANTA ANA,  CA  92799
Applicant Contact KRISTA U SMALLEY
Correspondent
BAXTER HEALTHCARE CORP.
P.O. BOX 25101
SANTA ANA,  CA  92799
Correspondent Contact KRISTA U SMALLEY
Regulation Number862.1150
Classification Product Code
JIX  
Date Received11/09/1987
Decision Date 01/05/1988
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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