Gen-Probe, Inc.

FDA 510(k) & PMA Approved Devices — 62 products

Total Devices62

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Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K122062	APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER	OUY	2013-01-09	View
510(k)	K111409	APTIMA COMBO 2 ASSAY	LSL	2012-05-03	View
510(k)	K063664	GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091	LSL	2007-01-25	View
510(k)	K063451	GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199	MKZ	2007-01-22	View
510(k)	K062440	GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091	LSL	2006-11-07	View
510(k)	K061413	APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM	MKZ	2006-10-13	View
510(k)	K061509	TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196	LSL	2006-10-04	View
510(k)	K060652	TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY	LSL	2006-08-17	View
510(k)	K053446	GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088	MKZ	2006-07-25	View
510(k)	K043224	GEN-PROBE APTIMA COMBO 2 ASSAY	LSL	2005-08-09	View
510(k)	K043144	GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE	LSL	2005-03-14	View
510(k)	K043072	GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS	MKZ	2005-01-27	View
510(k)	K032554	GEN-PROBE APTIMA COMBO 2 ASSAY	LSL	2003-12-31	View
510(k)	K032194	TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS	LSL	2003-12-24	View
510(k)	K022874	GEN-PROBE APTIMA COMBO 2 ASSAY	JTW	2002-09-17	View
510(k)	K003395	GEN-PROBE APTIMA COMBO 2 ASSAY	LSL	2001-05-21	View
510(k)	K962217	GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT	MKZ	1996-11-27	View
510(k)	K940979	GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORR	LSL	1994-10-31	View
510(k)	K920301	PACE 2 NEISSERIA GONORRHOEAE PROBE CONFIRM. ASSAY	LSL	1994-04-26	View
510(k)	K920302	PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAY	LSK	1994-04-06	View