FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM
FDA 510(k) clearance K904795 · decided 1990-12-31
Clearance details
- K-number
- K904795
- Device name
- FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1990-10-19
- Decision date
- 1990-12-31
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- GKH
- Device class
- 1
- Regulation number
- 864.5240
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Franklin Lakes, NJ, 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 |
|---|---|---|
| CELLTRACKS AUTOPREP SYSTEM MODEL:9541 (K100684) | Veridex, LLC | 2010-08-26 |
| IMMUNICON CELLTRACKS AUTOPREP SYSTEM (K040077) | Immunicon Corp. | 2004-03-12 |
| CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518 (K022512) | Immunicon Corp. | 2002-09-30 |
| COULTER CELLPREP (K021150) | Beckman Coulter, Inc. | 2002-06-11 |
| COULTER MULTI Q PREP (K935953) | Coulter Corp. | 1994-03-11 |
| COULTER MULTI-Q-PREP (K923530) | Coulter Electronics, Inc. | 1992-10-14 |
| SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM (K882767) | Toa Medical Electronics USA, Inc. | 1988-07-18 |
| AD150, AUTOMATED HEMATOLOGY DILUTOR (K852373) | Abbott Diagnostics | 1985-07-05 |
| HYCEL DILUTOR, VARIOUS MODELS/MULTI (K842747) | R&D Systems, Inc. | 1984-10-01 |
| DILU-MATIC 140 (K842446) | Abbott Diagnostics | 1984-09-06 |
| DILULAB 230 (K823522) | Innovative Medical Systems, Inc. | 1982-12-28 |
| ROYCO MODEL 371 SUPER DILUTOR (K791644) | Royco Instruments | 1979-09-19 |
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 |