BECTON DICKINSON LOGIC BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k) clearance K022581 · decided 2002-10-09
Clearance details
- K-number
- K022581
- Device name
- BECTON DICKINSON LOGIC BLOOD GLUCOSE MONITORING SYSTEM
- Applicant
- Becton, Dickinson & CO
- Decision
- Substantially Equivalent
- Date received
- 2002-08-05
- Decision date
- 2002-10-09
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- NBW
- Device class
- 2
- Regulation number
- 862.1345
- 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 Test Strips. The US market BD Test Strips are identified by Catalog Numbers 322027 (50 recall (Z-0763-04) | Becton Dickinson & Company | 2004-07-20 |
| BD Blood Glucose Test strips. BD Latitude, 100 Test Strips 100 Bandelettes Reactives, Manu recall (Z-1221-03) | Becton Dickinson & Company | 2003-09-11 |