510(k) K011043
- Device
- OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)
- Applicant
- OSMETECH
- 510(k) number
- K011043
- Product code
- JXA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-11-30
- Date received
- 2001-04-05
- Regulation
- 866.2660
- Classification name
- Kit, Screening, Urine
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN PLANT
- Address
- Electra House, Electra Way Crewe GB CW1 6WZ CW1 6WZ
FDA Registration Numbers#
- 3038206980
- 8020667
- 3011369203
- 8030124
- 3010230734
- 9615755
- 2027344
- 3008987086
- 1220502
- 1417592
- 3043127699
- 2022435
- 3015341499
- 1832216
- 2013736
- 3007478714
- 3035374295
- 2250039
- 1423537
- 3006191977
- 3024171133
- 3014255036
- 3008337059
- 3004043187
- 3009307598
- 1036781
- 2030633
Source Documents#
Other 510(k) Records For Product Code JXA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K981084 | URISCREEN | Diatech Diagnostics,Inc. | 1998-10-07 |
| K972676 | URINE SCREENING DEVICE | Combact Diagnostic Systems , Ltd. | 1998-02-23 |
| K952246 | TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT | Tri-Tech, Inc. | 1995-06-20 |
| K950257 | MULTIPLE (IZON DBS & URINE COLLECTION KIT) | Izon Business Products, Inc. | 1995-04-14 |
| K950246 | MULTIPLE (IZON URINE COLLECTION KIT) | Izon Business Products, Inc. | 1995-03-21 |
| K950221 | MULTIPLE (IZON BLOOD & URINE COLLECTION KIT) | Izon Business Products, Inc. | 1995-03-21 |
| K934759 | CULTURIA MACCONKEY-MUG | Clinical Convenience Products, Inc. | 1994-09-09 |
| K924218 | BAC-T-SCREEN | Biomerieux Vitek, Inc. | 1993-02-03 |
| K921045 | DIASLIDE URINE CULTURING DEVICE | Savyon Diagnostics , Ltd. | 1992-09-28 |
| K911846 | URI-THREE(TM), MODIFICATION | Culture Kits, Inc. | 1991-10-04 |
| K903470 | QUALTURE | Future Medical Technologies Intl., Inc. | 1990-12-13 |
| K894805 | RAPIDEC UR | Dms Products, Inc. | 1989-09-26 |
| K892216 | GEN-PROBE PACE SYSTEM URINE SCREEN | Gen-Probe, Inc. | 1989-09-15 |
| K882211 | URISCREEN | Diatech Diagnostica , Ltd. | 1988-09-30 |
| K883385 | RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TEST | Los Alamos Diagnostics | 1988-09-07 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases