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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tetrabromo-M-Cresolsulfonphthalein, Albumin
510(k) Number K972706
FOIA Releasable 510(k) K972706
Device Name CLINITEK MICROALBUMIN REAGENT STRIPS
Applicant
BAYER CORP.
1884 MILES AVE.
ELKHART,  IN  46514
Applicant Contact ROSANNE M SAVOL
Correspondent
BAYER CORP.
1884 MILES AVE.
ELKHART,  IN  46514
Correspondent Contact ROSANNE M SAVOL
Regulation Number862.1035
Classification Product Code
CJG  
Subsequent Product Code
JFY  
Date Received07/21/1997
Decision Date 09/09/1997
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
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