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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
510(k) Number K963142
Device Name DCA 2000 + MICROALBUMIN/CREATININE ASSAY
Applicant
Bayer Corp.
1884 Miles Ave.
P.O. Box 70
Elkhart,  IN  46514 -0070
Applicant Contact ROSANNE M SAVOL, R.A.C.
Correspondent
Bayer Corp.
1884 Miles Ave.
P.O. Box 70
Elkhart,  IN  46514 -0070
Correspondent Contact ROSANNE M SAVOL, R.A.C.
Regulation Number862.1645
Classification Product Code
JIR  
Date Received08/13/1996
Decision Date 09/27/1996
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
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