510(k) K896236
- Device
- Cobas Ready Bun Reagent
- Applicant
- ROCHE DIAGNOSTIC SYSTEMS, INC.
- 510(k) number
- K896236
- Product code
- JGZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-02-27
- Date received
- 1989-10-30
- Regulation
- 862.1770
- Classification name
- O-Phthalaldehyde, Urea Nitrogen
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ALEX WESOLOWSKI
- Address
- One Sunset Ave. Montclair NJ US 07042 07042
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JGZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K904049 | ROCHE COBAS READY RENAL PROFILE REAGENT STRIP | Roche Diagnostic Systems, Inc. | 1990-10-12 |
| K883327 | CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST | Heraeus Kulzer, Inc. | 1989-01-23 |
| K863901 | IQ UREA NITROGEN | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-11-24 |
| K842772 | PHARMACIA B2-MICRO RIA | Pharmacia, Inc. | 1984-11-01 |
| K840213 | BLOOD UREA NITROGEN REAGENT SYS | Sclavo, Inc. | 1984-03-19 |
| K820418 | K.D. COLORIMETRIC BLOOD UREA N2 TEST | King Diagnostics, Inc. | 1982-03-11 |
| K810087 | UREA NITROGEN, KINETIC | Bio-Analytics Laboratories, Inc. | 1981-02-26 |
| K801269 | SERALYZER BLOOD UREA NITROGEN(BUN) | Miles Laboratories, Inc. | 1980-07-08 |
| K792362 | BLOOD UREA NITROGEN REAGENT | Connecticut Diagnostics, Ltd. | 1979-12-06 |
| K770504 | REAGENT SYSTEM | American Monitor Corp. | 1977-06-27 |