FDA 510(k) Applications for Medical Device Product Code: JLX (Radioimmunoassay, 17-Hydroxyprogesterone)

FDA 510(k) Applications for Medical Device Product Code "JLX"
(Radioimmunoassay, 17-Hydroxyprogesterone)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K973350	BIO-RAD	BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST	02/09/1998
K062534	DRG INTL., INC.	ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE	01/29/2008
K060452	NEO-GENESIS	ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH	03/13/2007
K042425	WALLAC OY	AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT	09/30/2004
K081922	WALLAC OY	AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT	04/16/2009
K042424	WALLAC OY	DELFIA NEONATAL 17A-OH-PROGESTERONE KIT	09/30/2004
K100682	WALLAC OY	GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U	07/23/2010
K050960	WALLAC OY	MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT	07/11/2005