Product code JGZ— Clinical Chemistry
BLOOD UREA NITROGEN REAGENT
- Classification name
- O-Phthalaldehyde, Urea Nitrogen
- Device class
- Class 2
- Regulation
- 21 CFR 862.1770
- Advisory panel
- Clinical Chemistry
- Total cleared
- 11
- First cleared
- Most recent
Market context for product code JGZ
FDA has cleared devices under product code JGZ between 1977 and 1990, filed by 10 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1990
- 1989
- 1986
- 1984
- 1982
- 1981
- 1980
- 1979
- 1977
Top applicants under product code JGZ
Recent clearances under product code JGZ
- K904049 — ROCHE COBAS READY RENAL PROFILE REAGENT STRIP
- K896236 — COBAS READY BUN REAGENT
- K883327 — CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST
- K863901 — IQ UREA NITROGEN
- K842772 — PHARMACIA B2-MICRO RIA
- K840213 — BLOOD UREA NITROGEN REAGENT SYS
- K820418 — K.D. COLORIMETRIC BLOOD UREA N2 TEST
- K810087 — UREA NITROGEN, KINETIC
- K801269 — SERALYZER BLOOD UREA NITROGEN(BUN)
- K792362 — BLOOD UREA NITROGEN REAGENT
- K770504 — REAGENT SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.