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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 K951750
Device Name GLUCOSE TEST ITEM NUMBER 97375/94
Applicant
Emd Chemicals, Inc.
480 S. Democrat Rd.
Gibbstown,  NJ  08027
Applicant Contact CAROL FAULKNER
Correspondent
Emd Chemicals, Inc.
480 S. Democrat Rd.
Gibbstown,  NJ  08027
Correspondent Contact CAROL FAULKNER
Regulation Number862.1345
Classification Product Code
LFR  
Date Received04/17/1995
Decision Date 09/06/1995
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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