The following data is part of a premarket notification filed by Roche Molecular Systems, Inc. with the FDA for Roche Amplicor Ct/ng Test For Neisseria Gonorrhoeae.
| Device ID | K974503 |
| 510k Number | K974503 |
| Device Name: | ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE |
| Classification | Dna-reagents, Neisseria |
| Applicant | ROCHE MOLECULAR SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Somerville, NJ 08876 -3711 |
| Contact | Alex Wesolowski |
| Correspondent | Alex Wesolowski ROCHE MOLECULAR SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Somerville, NJ 08876 -3711 |
| Product Code | LSL |
| CFR Regulation Number | 866.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-28 |
| Decision Date | 1999-12-01 |
| Summary: | summary |