BD MICROTAINER MAP MICROTUBE FOR AUTOMATED PROCESS, MODEL 363706
FDA 510(k) clearance K093972 · decided 2010-01-21
Clearance details
- K-number
- K093972
- Device name
- BD MICROTAINER MAP MICROTUBE FOR AUTOMATED PROCESS, MODEL 363706
- Applicant
- Becton, Dickinson & CO
- Decision
- Substantially Equivalent
- Date received
- 2009-12-24
- Decision date
- 2010-01-21
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- JKA
- Device class
- 2
- Regulation number
- 862.1675
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Franklin Lakes, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BD Microtainer MAP Microtube for Automated Process with K2EDTA. For the collection, transp recall (Z-0176-2012) | Becton Dickinson & Company | 2011-11-08 |