JGZ — O-Phthalaldehyde, Urea Nitrogen Class II
FDA Device Classification
Classification Details
- Product Code
- JGZ
- Device Class
- Class II
- Regulation Number
- 862.1770
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K904049 | roche diagnostic systems | ROCHE COBAS READY RENAL PROFILE REAGENT STRIP | October 12, 1990 |
| K896236 | roche diagnostic systems | COBAS READY BUN REAGENT | February 27, 1990 |
| K883327 | heraeus kulzer | CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST | January 23, 1989 |
| K863901 | bd becton dickinson vacutainer systems preanalytic | IQ UREA NITROGEN | November 24, 1986 |
| K842772 | pharmacia | PHARMACIA B2-MICRO RIA | November 1, 1984 |
| K840213 | sclavo | BLOOD UREA NITROGEN REAGENT SYS | March 19, 1984 |
| K820418 | king diagnostics | K.D. COLORIMETRIC BLOOD UREA N2 TEST | March 11, 1982 |
| K810087 | bio-analytics laboratories | UREA NITROGEN, KINETIC | February 26, 1981 |
| K801269 | miles laboratories | SERALYZER BLOOD UREA NITROGEN(BUN) | July 8, 1980 |
| K792362 | connecticut diagnostics | BLOOD UREA NITROGEN REAGENT | December 6, 1979 |
| K770504 | american monitor | REAGENT SYSTEM | June 27, 1977 |