Blood Urea Nitrogen Reagent
FDA 510(k) K792362 · Connecticut Diagnostics, Ltd.
510(k) numberK792362
Submission
- Device name
- Blood Urea Nitrogen Reagent
- Applicant
- Connecticut Diagnostics, Ltd.
Mchenry, IL, US - Received
- November 21, 1979
- Decision date
- December 6, 1979
- 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 |
| 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 |
| K770504 | Reagent SystemJGZ · Traditional | American Monitor Corp. | 06/27/1977SE |
More from American Monitor Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K905617 | Visi-StaphJWX · Traditional | 03/29/1991SE |
| K822504 | CDL Auto-Lysing ReagentGGK · Traditional | 09/17/1982SE |
| K822501 | CDL Isotonic DiluentGIF · Traditional | 09/17/1982SE |
| K822500 | CDL Lysing ReagentGGK · Traditional | 09/17/1982SE |
| K811222 | Inorganic Phosphorus ReagentsCED · Traditional | 05/21/1981SE |
| K801898 | Uric Acid Diagnostic ReagentKNK · Traditional | 10/10/1980SE |
| K801897 | Glucose Diagnostic ReagentCGA · Traditional | 10/10/1980SE |
| K792465 | Connecticut Diagnostics, Lts. DirectCIG · Traditional | 12/18/1979SE |
| K792340 | Connect. Diag. Total Protein Diag. ReageCEK · Traditional | 12/06/1979SE |
| K792339 | Connect. Diag. Albumin Diagnostic ReagenCIX · Traditional | 12/06/1979SE |
Questions and answers
When was Blood Urea Nitrogen Reagent cleared by the FDA?
Blood Urea Nitrogen Reagent (K792362) received a 510(k) decision of Substantially Equivalent on December 6, 1979, 15 days after the submission was received.
What is the product code of K792362?
The FDA product code is JGZ – O-Phthalaldehyde, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.