FDA 510(k) Application Details - K062534

Device Classification Name	Radioimmunoassay, 17-Hydroxyprogesterone   More FDA Info for this Device
510(K) Number	K062534
Device Name	Radioimmunoassay, 17-Hydroxyprogesterone
Applicant	DRG INTL., INC. 150 CHERRY LANE RD. EAST STROUDSBURG, PA 18301 US Other 510(k) Applications for this Company
Contact	Gary Lehnus Other 510(k) Applications for this Contact
Regulation Number	862.1395   More FDA Info for this Regulation Number
Classification Product Code	JLX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/29/2006
Decision Date	01/29/2008
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