BIO-PRO UNIT
FDA 510(k) clearance K781303 · decided 1978-10-02
Clearance details
- K-number
- K781303
- Device name
- BIO-PRO UNIT
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1978-07-27
- Decision date
- 1978-10-02
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- FKR
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Washington, DC, 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 |
|---|---|---|
| NXSTAGE PUREFLOW SL (K140571) | Nxstage Medical, Inc. | 2014-05-15 |
| NXSTAGE PUREFLOW SL (K111174) | Nxstage Medical, Inc. | 2011-09-19 |
| NXSTAGE PUREFLOW SL (K080919) | Nxstage Medical, Inc. | 2008-10-15 |
| NXSTAGE DIALYSATE PREPARATION MODULE (K060296) | Nxstage Medical, Inc. | 2006-03-31 |
| NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269 (K043436) | Nxstage Medical, Inc. | 2005-03-17 |
| SARTORIUS AQUASART SM 40035 - DIALYSATE SYS (K850435) | Sartorius Filters, Inc. | 1985-06-04 |
| AUTO-D AUTOMATIC DISINFECTION ACCESS/ATTACHMENTS (K850756) | Travenol Laboratories, S.A. | 1985-03-20 |
| CHEMATIC BICARBONATE DIALYSATE SYSTEM (K810605) | Trimedyne, Inc. | 1981-06-16 |
| GAMBRO BICARBONATE MODULE, BCM-10 (K810127) | Gambro, Inc. | 1981-02-25 |
| BICARB-O-MATE HEMODIALYSIS SOD. BICARB. (K802465) | Renal Systems, Inc. | 1980-11-12 |
| MOD. DM-357 BICARBONATE RETROFIT KIT (K800772) | Extracorporeal Medical Specialities, Inc. | 1980-05-14 |
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 |