BD FACS SAMPLE PREP ASSISTANT III
FDA 510(k) clearance K131301 · decided 2013-08-02
Clearance details
- K-number
- K131301
- Device name
- BD FACS SAMPLE PREP ASSISTANT III
- Applicant
- Becton, Dickinson & CO
- Decision
- Substantially Equivalent
- Date received
- 2013-05-07
- Decision date
- 2013-08-02
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- PER
- Device class
- 1
- Regulation number
- 862.2750
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Becton
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 |
|---|---|---|
| TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION (K130253) | Beckman Coulter, Inc. | 2013-07-15 |
| MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE (K050191) | Becton, Dickinson & CO | 2005-02-22 |
Recalls involving this device
No recalls on record reference this clearance.