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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ion-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen
510(k) Number K961984
Device Name PORPHOBILINOGEN (PBG)
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 Number862.1590
Classification Product Code
JNF  
Date Received05/21/1996
Decision Date 12/10/1996
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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