BD VIPER LT SYSTEM
FDA 510(k) clearance K140447 · decided 2014-05-20
Clearance details
- K-number
- K140447
- Device name
- BD VIPER LT SYSTEM
- Applicant
- Becton, Dickinson and Company
- Decision
- Substantially Equivalent
- Date received
- 2014-02-21
- Decision date
- 2014-05-20
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- OOI
- Device class
- 2
- Regulation number
- 862.2570
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Sparks, MD, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| BD Viper LT software, version 3.00H recall (Z-1866-2017) | Bd Diagnostic | 2017-04-04 |
| BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Ch recall (Z-1816-2015) | Becton Dickinson & Co. | 2015-06-18 |
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|---|---|---|
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