MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE
FDA 510(k) clearance K050191 · decided 2005-02-22
Clearance details
- K-number
- K050191
- Device name
- MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE
- Applicant
- Becton, Dickinson & CO
- Decision
- Substantially Equivalent
- Date received
- 2005-01-27
- Decision date
- 2005-02-22
- Days to decision
- 26 days
- Clearance type
- Special
- 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
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| BD FACS SAMPLE PREP ASSISTANT III (K131301) | Becton, Dickinson & CO | 2013-08-02 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BD Biosciences, BD FACS Sample Prep Assistant II (SPA II), blood sample preparer for flow recall (Z-1940-2010) | BD Biosciences, Systems & Reagents | 2010-06-30 |
| BD FACS Sample Prep Assistant II, Part Number: 337170; Product is manufactured and distrib recall (Z-0526-2008) | BD Biosciences | 2008-04-10 |