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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Method, Ammonia
510(k) Number K974620
Device Name AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)
Applicant
Trace America, Inc.
7260 NW 58th St.
Miami,  FL  33166
Applicant Contact DAVID JOHNSON
Correspondent
Trace America, Inc.
7260 NW 58th St.
Miami,  FL  33166
Correspondent Contact DAVID JOHNSON
Regulation Number862.1065
Classification Product Code
JIF  
Date Received12/11/1997
Decision Date 01/02/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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