The following data is part of a premarket notification filed by Osmetech with the FDA for Osmetech Microbial Analyser-urinary Tract Infection Detector (oma-uti).
| Device ID | K011043 |
| 510k Number | K011043 |
| Device Name: | OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI) |
| Classification | Kit, Screening, Urine |
| Applicant | OSMETECH ELECTRA HOUSE ELECTRA WAY Crewe, GB Cw1 6wz |
| Contact | John Plant |
| Correspondent | John Plant OSMETECH ELECTRA HOUSE ELECTRA WAY Crewe, GB Cw1 6wz |
| Product Code | JXA |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-05 |
| Decision Date | 2001-11-30 |