JGZ — O-Phthalaldehyde, Urea Nitrogen Class II
FDA product code JGZ covers "O-Phthalaldehyde, Urea Nitrogen", a Class II medical device regulated under 21 CFR 862.1770. Submissions are reviewed by the Clinical Chemistry panel. At least 11 recent 510(k) clearances have been granted under this product code.
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 |