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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Dehydrogenase, Glucose
510(k) Number K004010
Device Name ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT COMPACT CONTROLS
Applicant
Roche Diagnostics Corp.
9115 Hague Rd., P.O. Box 50457
Indianapolis,  IN  46250
Applicant Contact LUANN OCHS
Correspondent
Roche Diagnostics Corp.
9115 Hague Rd., P.O. Box 50457
Indianapolis,  IN  46250
Correspondent Contact LUANN OCHS
Regulation Number862.1345
Classification Product Code
LFR  
Date Received12/26/2000
Decision Date 04/26/2001
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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