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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name multi-analyte controls, all kinds (assayed)
510(K) Number K920636
Device Name DADE URINE CHEMISTRY CONTROL LEVELS I AND II
Applicant
BAXTER DIAGNOSTICS, INC.
p.o. box 520672
miami,  FL  33152
Contact alodia m ruiz
Regulation Number862.1660
Classification Product Code
JJY  
Date Received02/12/1992
Decision Date 07/07/1992
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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