FDA 510(k) Application Details - K030730

Device Classification Name	Radioimmunoassay, Testosterones And Dihydrotestosterone   More FDA Info for this Device
510(K) Number	K030730
Device Name	Radioimmunoassay, Testosterones And Dihydrotestosterone
Applicant	DIAGNOSTICS BIOCHEM CANADA, INC. 1020 HARGRIEVE RD. LONDON, ONTARIO N6E 1P5 CA Other 510(k) Applications for this Company
Contact	G. R DUMONT Other 510(k) Applications for this Contact
Regulation Number	862.1680   More FDA Info for this Regulation Number
Classification Product Code	CDZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/10/2003
Decision Date	08/18/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review