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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nadh Oxidation/Nad Reduction, Alt/Sgpt
510(k) Number K843334
Device Name SYSTEMATE GPT 67209
Applicant
Em Diagnostic Systems, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Em Diagnostic Systems, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1030
Classification Product Code
CKA  
Date Received08/27/1984
Decision Date 09/20/1984
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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