JXA — Kit, Screening, Urine Class I
FDA Device Classification
Classification Details
- Product Code
- JXA
- Device Class
- Class I
- Regulation Number
- 866.2660
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K011043 | osmetech | OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI) | November 30, 2001 |
| K981084 | diatech diagnostics | URISCREEN | October 7, 1998 |
| K972676 | combact diagnostic systems | URINE SCREENING DEVICE | February 23, 1998 |
| K952246 | tri-tech | TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT | June 20, 1995 |
| K950257 | izon business products | MULTIPLE (IZON DBS & URINE COLLECTION KIT) | April 14, 1995 |
| K950246 | izon business products | MULTIPLE (IZON URINE COLLECTION KIT) | March 21, 1995 |
| K950221 | izon business products | MULTIPLE (IZON BLOOD & URINE COLLECTION KIT) | March 21, 1995 |
| K934759 | clinical convenience products | CULTURIA MACCONKEY-MUG | September 9, 1994 |
| K924218 | biomerieux vitek | BAC-T-SCREEN | February 3, 1993 |
| K921045 | savyon diagnostics | DIASLIDE URINE CULTURING DEVICE | September 28, 1992 |
| K911846 | culture kits | URI-THREE(TM), MODIFICATION | October 4, 1991 |
| K903470 | future medical technologies intl | QUALTURE | December 13, 1990 |
| K894805 | dms products | RAPIDEC UR | September 26, 1989 |
| K892216 | gen-probe | GEN-PROBE PACE SYSTEM URINE SCREEN | September 15, 1989 |
| K882211 | diatech diagnostica | URISCREEN | September 30, 1988 |
| K883385 | los alamos diagnostics | RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TEST | September 7, 1988 |
| K881439 | los alamos diagnostics | MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEM | April 28, 1988 |
| K873086 | bioclinical systems | ROUND 1 | August 24, 1987 |
| K870731 | micro-bio-logics | LYFO KWIK(TM) RUS KIT | June 17, 1987 |
| K864177 | cls | N-D URINE TUBE SYSTEM (N-D TUBE/CAP/PIPETTE) | February 24, 1987 |