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FDA 510(k) Application Details - K052242
Device Classification Name
Urinalysis Controls (Assayed And Unassayed)
More FDA Info for this Device
510(K) Number
K052242
Device Name
Urinalysis Controls (Assayed And Unassayed)
Applicant
BAYER HEALTHCARE LLC
511 BENEDICT AVE.
TARRYTOWN, NY 10591 US
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Contact
ANDRES HOLLE
Other 510(k) Applications for this Contact
Regulation Number
862.1660
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Classification Product Code
JJW
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More FDA Info for this Product Code
Date Received
08/17/2005
Decision Date
10/03/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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