FDA 510(k) Application Details - K040181

Device Classification Name	Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)   More FDA Info for this Device
510(K) Number	K040181
Device Name	Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
Applicant	BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 BREA, CA 92822 US Other 510(k) Applications for this Company
Contact	MARY BETH TANG Other 510(k) Applications for this Contact
Regulation Number	862.1245   More FDA Info for this Regulation Number
Classification Product Code	JKC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/27/2004
Decision Date	03/24/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review