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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 K940215
Device Name GLUCOCHEK
Applicant
Clinical Diagnostics, Inc.
132 Main St., Suite A
Chester,  SC  29706
Applicant Contact CHARLES F NEILSON
Correspondent
Clinical Diagnostics, Inc.
132 Main St., Suite A
Chester,  SC  29706
Correspondent Contact CHARLES F NEILSON
Regulation Number862.1345
Classification Product Code
CGA  
Date Received01/14/1994
Decision Date 01/17/1995
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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