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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Porphyrin, Spectrophotometry, Lithium
510(k) Number K050374
Device Name ADVIA IMS LITHIUM ASSAY
Applicant
BAYER HEALTHCARE, LLC
511 BENEDICT AVE.
TARRYTOWN,  NY  10591
Applicant Contact ANDRES HOLLE
Correspondent
BAYER HEALTHCARE, LLC
511 BENEDICT AVE.
TARRYTOWN,  NY  10591
Correspondent Contact ANDRES HOLLE
Regulation Number862.3560
Classification Product Code
NDW  
Subsequent Product Codes
JIX   JJY  
Date Received02/14/2005
Decision Date 06/15/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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