Urea Nitrogen, Kinetic
FDA 510(k) K810087 · Bio-Analytics Laboratories, Inc.
510(k) numberK810087
Submission
- Device name
- Urea Nitrogen, Kinetic
- Applicant
- Bio-Analytics Laboratories, Inc.
Mchenry, IL, US - Received
- January 13, 1981
- Decision date
- February 26, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JGZ – O-Phthalaldehyde, Urea Nitrogen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1770
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JGZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K904049 | Roche Cobas Ready Renal Profile Reagent StripJGZ · Traditional | Roche Diagnostic Systems, Inc. | 10/12/1990SE |
| K896236 | Cobas Ready Bun ReagentJGZ · Traditional | Roche Diagnostic Systems, Inc. | 02/27/1990SE |
| K883327 | Clinistat Bun (Blood Urea Nitrogen) Reagent TestJGZ · Traditional | Heraeus Kulzer, Inc. | 01/23/1989SE |
| K863901 | Iq Urea NitrogenJGZ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 11/24/1986SE |
| K842772 | Pharmacia B2-MICRO RiaJGZ · Traditional | Pharmacia, Inc. | 11/01/1984SE |
| K840213 | Blood Urea Nitrogen Reagent SysJGZ · Traditional | Sclavo, Inc. | 03/19/1984SE |
| K820418 | K.D. Colorimetric Blood Urea N2 TestJGZ · Traditional | King Diagnostics, Inc. | 03/11/1982SE |
| K801269 | Seralyzer Blood Urea Nitrogen(Bun)JGZ · Traditional | Miles Laboratories, Inc. | 07/08/1980SE |
| K792362 | Blood Urea Nitrogen ReagentJGZ · Traditional | Connecticut Diagnostics, Ltd. | 12/06/1979SE |
| K770504 | Reagent SystemJGZ · Traditional | American Monitor Corp. | 06/27/1977SE |
More from American Monitor Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K861638 | Kinetic Alkaline Phosphatase Reagent KitCJE · Traditional | 05/29/1986SE |
| K860245 | Enzymatic Alpha-Amylase Reagent KitJFJ · Traditional | 03/14/1986SE |
| K860213 | Albumin Reagent KitCIX · Traditional | 02/11/1986SE |
| K851514 | Ultra-Violet Glucose ReagentCFA · Traditional | 05/20/1985SE |
| K851513 | Ultra-Violet Bun Reagent KitCDQ · Traditional | 05/20/1985SE |
| K850639 | Enzymatic Alpha-Amylase Reagent KitCIW · Traditional | 03/05/1985SE |
| K832771 | Erythrocyte TestLKZ · Traditional | 10/28/1983SE |
| K832567 | Acetaminophen(ParacetamolLDP · Traditional | 09/12/1983SE |
| K831414 | Colorimetric BunCDL · Traditional | 06/16/1983SE |
| K821934 | Bio-Cal Operation Check KitJIS · Traditional | 07/20/1982SE |
Questions and answers
When was Urea Nitrogen, Kinetic cleared by the FDA?
Urea Nitrogen, Kinetic (K810087) received a 510(k) decision of Substantially Equivalent on February 26, 1981, 44 days after the submission was received.
What is the product code of K810087?
The FDA product code is JGZ – O-Phthalaldehyde, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.