JGZ
11 FDA 510(k) clearances · Product code
48 daysmedian time to decision
120 days90th percentile
11clearances measured
FDA profile
- Official device name
- O-Phthalaldehyde, Urea Nitrogen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1770
- Medical specialty
- Clinical Chemistry
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ROCHE COBAS READY RENAL PROFILE REAGENT STRIP (K904049) | Roche Diagnostic Systems, Inc. | 1990-10-12 |
| COBAS READY BUN REAGENT (K896236) | Roche Diagnostic Systems, Inc. | 1990-02-27 |
| CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST (K883327) | Heraeus Kulzer, Inc. | 1989-01-23 |
| IQ UREA NITROGEN (K863901) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-11-24 |
| PHARMACIA B2-MICRO RIA (K842772) | Pharmacia, Inc. | 1984-11-01 |
| BLOOD UREA NITROGEN REAGENT SYS (K840213) | Sclavo, Inc. | 1984-03-19 |
| K.D. COLORIMETRIC BLOOD UREA N2 TEST (K820418) | King Diagnostics, Inc. | 1982-03-11 |
| UREA NITROGEN, KINETIC (K810087) | Bio-Analytics Laboratories, Inc. | 1981-02-26 |
| SERALYZER BLOOD UREA NITROGEN(BUN) (K801269) | Miles Laboratories, Inc. | 1980-07-08 |
| BLOOD UREA NITROGEN REAGENT (K792362) | Connecticut Diagnostics, Ltd. | 1979-12-06 |
| REAGENT SYSTEM (K770504) | American Monitor Corp. | 1977-06-27 |
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Every clearance here is in the API, with alerts when new ones post.