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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 K992257
Device Name NEW MULTIPLES REAGENT STRIPS
Applicant
BAYER CORP.
1884 MILES AVE.
ELKHART,  IN  46514
Applicant Contact SYED ATAULLAH
Correspondent
BAYER CORP.
1884 MILES AVE.
ELKHART,  IN  46514
Correspondent Contact SYED ATAULLAH
Regulation Number862.1645
Classification Product Code
JIR  
Subsequent Product Codes
CDM   CEN   JFY   JIL   JIN  
JIO   JJB   JMT   JRE   LJX  
Date Received07/06/1999
Decision Date 11/24/1999
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
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