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FDA 510(k) Application Details - K960546
Device Classification Name
Automated Urinalysis System
More FDA Info for this Device
510(K) Number
K960546
Device Name
Automated Urinalysis System
Applicant
BAYER CORP.
1884 MILES AVE.
P.O. BOX 70
ELKHART, IN 46514-0070 US
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Contact
ROSANNE M SAVOL
Other 510(k) Applications for this Contact
Regulation Number
862.2900
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Classification Product Code
KQO
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More FDA Info for this Product Code
Date Received
02/08/1996
Decision Date
06/12/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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