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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Turbidimetric, Total Protein
510(k) Number K925794
FOIA Releasable 510(k) K925794
Device Name TRACE MICROPROTEIN REAGENT
Applicant
Trace America, Inc.
7260 NW 58th St.
Miami,  FL  33166
Applicant Contact David Johnston
Correspondent
Trace America, Inc.
7260 NW 58th St.
Miami,  FL  33166
Correspondent Contact David Johnston
Regulation Number862.1635
Classification Product Code
JGQ  
Date Received11/16/1992
Decision Date 03/29/1993
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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