FDA 510(k) Application Details - K031359

Device Classification Name	More FDA Info for this Device
510(K) Number	K031359
Device Name	S-MONOVETTE EDTA K2-GEL
Applicant	SARSTEDT, INC. 1025 ST. JAMES CHURCH RD. NEWTON, NC 28658 US Other 510(k) Applications for this Company
Contact	PETER RUMSWINKEL Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PJE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/30/2003
Decision Date	09/12/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review