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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name glucose oxidase, glucose
510(k) Number K924475
Device Name ACCUDATA GLUCOSE TEST STATION
Applicant
BOEHRINGER MANNHEIM CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250 -0457
Applicant Contact CYNTHIA A SPAIN
Correspondent
BOEHRINGER MANNHEIM CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250 -0457
Correspondent Contact CYNTHIA A SPAIN
Regulation Number862.1345
Classification Product Code
CGA  
Date Received09/03/1992
Decision Date 10/13/1992
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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