The following data is part of a premarket notification filed by Osmetech with the FDA for Osmetech Microbial Analyser-bacterial Vaginosis (oma-bv).
| Device ID | K023677 |
| 510k Number | K023677 |
| Device Name: | OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV) |
| Classification | Device, General Purpose, Microbiology, Diagnostic |
| Applicant | OSMETECH ELECTRA HOUSE ELECTRA WAY Crewe, GB |
| Contact | Andrew Tummon |
| Correspondent | Andrew Tummon OSMETECH ELECTRA HOUSE ELECTRA WAY Crewe, GB |
| Product Code | LIB |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-01 |
| Decision Date | 2003-01-29 |
| Summary: | summary |