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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name tryptase assay system
De Novo Number DEN120001
510(K) Number K103039
Device Name IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE
Requester
phadia us, inc.
4169 commercial ave.
portae,  MI  49002
Contact martin mann
Regulation Number866.5760
Classification Product Code
OYL  
Date Received01/12/2012
Decision Date 02/15/2012
Decision granted (DENG)
Classification Advisory Committee Immunology
Review Advisory Committee Immunology
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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