O-Phthalaldehyde, Urea Nitrogen
O-Phthalaldehyde for Urea Nitrogen is a clinical chemistry test system that uses o-phthalaldehyde reagent to measure blood urea nitrogen (BUN) levels, a key indicator of kidney function and protein metabolism. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification and adherence to general and special controls. The product code is JGZ, regulated under 21 CFR 862.1770, within the Clinical Chemistry medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- JGZ
- Device Class
- FDA class 2
- Regulation Number
- 862.1770
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K904049 | ROCHE COBAS READY RENAL PROFILE REAGENT STRIP | Oct 12, 1990 | Substantially Equivalent | Roche Diagnostic Systems, Inc. |
| K896236 | COBAS READY BUN REAGENT | Feb 27, 1990 | Substantially Equivalent | Roche Diagnostic Systems, Inc. |
| K883327 | CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST | Jan 23, 1989 | Substantially Equivalent | Heraeus Kulzer, Inc. |
| K863901 | IQ UREA NITROGEN | Nov 24, 1986 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K842772 | PHARMACIA B2-MICRO RIA | Nov 01, 1984 | Substantially Equivalent | Pharmacia, Inc. |
| K840213 | BLOOD UREA NITROGEN REAGENT SYS | Mar 19, 1984 | Substantially Equivalent | Sclavo, Inc. |
| K820418 | K.D. COLORIMETRIC BLOOD UREA N2 TEST | Mar 11, 1982 | Substantially Equivalent | King Diagnostics, Inc. |
| K810087 | UREA NITROGEN, KINETIC | Feb 26, 1981 | Substantially Equivalent | Bio-Analytics Laboratories, Inc. |
| K801269 | SERALYZER BLOOD UREA NITROGEN(BUN) | Jul 08, 1980 | Substantially Equivalent | Miles Laboratories, Inc. |
| K792362 | BLOOD UREA NITROGEN REAGENT | Dec 06, 1979 | Substantially Equivalent | Connecticut Diagnostics, Ltd. |
| K770504 | REAGENT SYSTEM | Jun 27, 1977 | Substantially Equivalent | American Monitor Corp. |