IQ UREA NITROGEN
FDA 510(k) clearance K863901 · decided 1986-11-24
Clearance details
- K-number
- K863901
- Device name
- IQ UREA NITROGEN
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1986-10-07
- Decision date
- 1986-11-24
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- JGZ
- Device class
- 2
- Regulation number
- 862.1770
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Franklin Lakes, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ROCHE COBAS READY RENAL PROFILE REAGENT STRIP (K904049) | Roche Diagnostic Systems, Inc. | 1990-10-12 |
| COBAS READY BUN REAGENT (K896236) | Roche Diagnostic Systems, Inc. | 1990-02-27 |
| CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST (K883327) | Heraeus Kulzer, Inc. | 1989-01-23 |
| PHARMACIA B2-MICRO RIA (K842772) | Pharmacia, Inc. | 1984-11-01 |
| BLOOD UREA NITROGEN REAGENT SYS (K840213) | Sclavo, Inc. | 1984-03-19 |
| K.D. COLORIMETRIC BLOOD UREA N2 TEST (K820418) | King Diagnostics, Inc. | 1982-03-11 |
| UREA NITROGEN, KINETIC (K810087) | Bio-Analytics Laboratories, Inc. | 1981-02-26 |
| SERALYZER BLOOD UREA NITROGEN(BUN) (K801269) | Miles Laboratories, Inc. | 1980-07-08 |
| BLOOD UREA NITROGEN REAGENT (K792362) | Connecticut Diagnostics, Ltd. | 1979-12-06 |
| REAGENT SYSTEM (K770504) | American Monitor Corp. | 1977-06-27 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OXYCELL (N5798/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-07-24 |
| OXYCEL OXIDIZED (N5798/S005) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| OXYCELL (N5798/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| MINI BALLOON (P780011/S012) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-10-30 |
| MINI BALLOON (P780011/S011) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-10-18 |
| MINI BALLOON (P780011/S010) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-01-29 |
| MINI BALLOON (P780011/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-01-23 |
| BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-11-05 |