FDA 510(k) Applications Submitted by GEN-PROBE, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K022874 |
07/26/2002 |
GEN-PROBE APTIMA COMBO 2 ASSAY |
GEN-PROBE, INC. |
| K032554 |
08/19/2003 |
GEN-PROBE APTIMA COMBO 2 ASSAY |
GEN-PROBE, INC. |
| K043072 |
11/08/2004 |
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS |
GEN-PROBE, INC. |
| K043144 |
11/15/2004 |
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE |
GEN-PROBE, INC. |
| K043224 |
11/22/2004 |
GEN-PROBE APTIMA COMBO 2 ASSAY |
GEN-PROBE, INC. |
| K060652 |
03/13/2006 |
TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY |
GEN-PROBE, INC. |
| K061413 |
05/22/2006 |
APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM |
GEN-PROBE, INC. |
| K061509 |
06/01/2006 |
TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196 |
GEN-PROBE, INC. |
| K053446 |
12/12/2005 |
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088 |
GEN-PROBE, INC. |
| K062440 |
08/21/2006 |
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091 |
GEN-PROBE, INC. |
| K003395 |
11/01/2000 |
GEN-PROBE APTIMA COMBO 2 ASSAY |
GEN-PROBE, INC. |
| K063451 |
11/15/2006 |
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199 |
GEN-PROBE, INC. |
| K063664 |
12/08/2006 |
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091 |
GEN-PROBE, INC. |
| K962217 |
06/10/1996 |
GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT |
GEN-PROBE, INC. |
| K111409 |
05/19/2011 |
APTIMA COMBO 2 ASSAY |
GEN-PROBE, INC. |
| K122062 |
07/13/2012 |
APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER |
GEN-PROBE, INC. |
| K032194 |
07/18/2003 |
TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS |
GEN-PROBE, INC. |
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