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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Urinalysis System
510(k) Number K960546
Device Name CLINITEK 50 URINE CHEMISTRY ANALYZER
Applicant
Bayer Corp.
1884 Miles Ave.
P.O. Box 70
Elkhart,  IN  46514
Applicant Contact ROSANNE M SAVOL
Correspondent
Bayer Corp.
1884 Miles Ave.
P.O. Box 70
Elkhart,  IN  46514
Correspondent Contact ROSANNE M SAVOL
Regulation Number862.2900
Classification Product Code
KQO  
Date Received02/08/1996
Decision Date 06/12/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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