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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name acid, uric, uricase (colorimetric)
510(k) Number K873363
Device Name URIC ACID PAP
Applicant
BOEHRINGER MANNHEIM CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250 -0457
Applicant Contact CHERI EMMONS
Correspondent
BOEHRINGER MANNHEIM CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250 -0457
Correspondent Contact CHERI EMMONS
Regulation Number862.1775
Classification Product Code
KNK  
Date Received08/21/1987
Decision Date 10/19/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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