Cobas Ready Bun Reagent
FDA 510(k) K896236 · Roche Diagnostic Systems, Inc.
510(k) numberK896236
Submission
- Device name
- Cobas Ready Bun Reagent
- Applicant
- Roche Diagnostic Systems, Inc.
Montclair, NJ, US - Received
- October 30, 1989
- Decision date
- February 27, 1990
- 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 |
| 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 |
| K792362 | Blood Urea Nitrogen ReagentJGZ · Traditional | Connecticut Diagnostics, Ltd. | 12/06/1979SE |
| K770504 | Reagent SystemJGZ · Traditional | American Monitor Corp. | 06/27/1977SE |
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Questions and answers
When was Cobas Ready Bun Reagent cleared by the FDA?
Cobas Ready Bun Reagent (K896236) received a 510(k) decision of Substantially Equivalent on February 27, 1990, 120 days after the submission was received.
What is the product code of K896236?
The FDA product code is JGZ – O-Phthalaldehyde, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.