FDA 510(k) Application Details - K040107

Device Classification Name	Tubes, Vials, Systems, Serum Separators, Blood Collection   More FDA Info for this Device
510(K) Number	K040107
Device Name	Tubes, Vials, Systems, Serum Separators, Blood Collection
Applicant	STRECK LABORATORIES, INC. 7002 SOUTH 109TH ST. LA VISTA, NE 68128 US Other 510(k) Applications for this Company
Contact	KERRIE OETTER Other 510(k) Applications for this Contact
Regulation Number	862.1675   More FDA Info for this Regulation Number
Classification Product Code	JKA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/20/2004
Decision Date	07/27/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review