K.D. Colorimetric Blood Urea N2 Test
FDA 510(k) K820418 · King Diagnostics, Inc.
510(k) numberK820418
Submission
- Device name
- K.D. Colorimetric Blood Urea N2 Test
- Applicant
- King Diagnostics, Inc.
Mchenry, IL, US - Received
- February 16, 1982
- Decision date
- March 11, 1982
- 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 |
| K810087 | Urea Nitrogen, KineticJGZ · Traditional | Bio-Analytics Laboratories, Inc. | 02/26/1981SE |
| 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 |
|---|---|---|
| K933329 | King Diagnostics Iron and Total Iron Binding Capacity ReagentJMO · Traditional | 10/22/1993SE |
| K931834 | King Sodium/Potassium Standard ModifiedJIS · Traditional | 08/25/1993SE |
| K931773 | HDL Precipitating Reagent (Dextran Sulfate)LBR · Traditional | 08/16/1993SE |
| K931326 | King Diagnostics CK ReagentCGS · Traditional | 06/15/1993SE |
| K923129 | King Diagnostics Glucose (HK) ReagentCFR · Traditional | 11/02/1992SE |
| K922969 | King Diagnostics Urea Nitrogen ReagentCDN · Traditional | 10/13/1992SE |
| K922921 | King Diagnostics Chloride ReagentCHJ · Traditional | 10/05/1992SE |
| K923927 | King Diagnostics Magnesium ReagentJGJ · Traditional | 09/30/1992SE |
| K923128 | King Diagnostics Cholesterol ReagentCHH · Traditional | 09/09/1992SE |
| K923091 | King Diagnostics Gamma GT ReagentJPZ · Traditional | 09/09/1992SE |
Questions and answers
When was K.D. Colorimetric Blood Urea N2 Test cleared by the FDA?
K.D. Colorimetric Blood Urea N2 Test (K820418) received a 510(k) decision of Substantially Equivalent on March 11, 1982, 23 days after the submission was received.
What is the product code of K820418?
The FDA product code is JGZ – O-Phthalaldehyde, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.