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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Lactic, Enzymatic Method
510(k) Number K951331
Device Name ACCUSPORT LACTATE MONITORING SYSTEM LACTATE TEST STRIPS ACCUSPORT MONITOR
Applicant
Boehringer Mannheim Corp.
9115 Hague Rd., P.O. Box 50457
Indianapolis,  IN  46250
Applicant Contact MIKE FLIS
Correspondent
Boehringer Mannheim Corp.
9115 Hague Rd., P.O. Box 50457
Indianapolis,  IN  46250
Correspondent Contact MIKE FLIS
Regulation Number862.1450
Classification Product Code
KHP  
Date Received03/24/1995
Decision Date 08/11/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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