The following data is part of a premarket notification filed by Roche Diagnostics Corporation with the FDA for Amplicor Ct/ng Test For Neisseria Gonorrhoeae.
| Device ID | K070172 |
| 510k Number | K070172 |
| Device Name: | AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE |
| Classification | Dna-reagents, Neisseria |
| Applicant | ROCHE DIAGNOSTICS CORPORATION 9115 HAGUE ROAD Indianapolis, IN 46256 |
| Contact | Theresa Ambrose Bush |
| Correspondent | Theresa Ambrose Bush ROCHE DIAGNOSTICS CORPORATION 9115 HAGUE ROAD Indianapolis, IN 46256 |
| Product Code | LSL |
| CFR Regulation Number | 866.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-18 |
| Decision Date | 2007-04-17 |
| Summary: | summary |