KIT, RADIOASSAY, SERUM IRON
FDA 510(k) clearance K760045 · decided 1976-07-20
Clearance details
- K-number
- K760045
- Device name
- KIT, RADIOASSAY, SERUM IRON
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1976-06-15
- Decision date
- 1976-07-20
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- JJA
- Device class
- 1
- Regulation number
- 862.1410
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Bd Becton Dickinson Vacutainer Systems Preanalytic
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SIMUL-FER SERUM IRON TEST KIT (K820253) | Diagnostic Reagents, Inc. | 1982-05-12 |
| DIAGNOSTIC KIT, FERRITAB-FE-59 (K782159) | Leeco Diagnostics, Inc. | 1979-02-01 |
| IRON 59 KIT (K781769) | Ria Products, Inc. | 1978-12-04 |
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 |