NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS
FDA 510(k) clearance K060345 · decided 2006-04-28
Clearance details
- K-number
- K060345
- Device name
- NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS
- Applicant
- Nova Biomedical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2006-02-10
- Decision date
- 2006-04-28
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- CGA
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Walham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Me recall (Z-0650-2014) | Nova Biomedical Corporation | 2014-01-09 |
| Nova StatStrip Glucose Test Strips, Catalog Number: 42214. Nova Biomedical Corporation. Wa recall (Z-1783-2010) | Nova Biomedical Corporation | 2010-06-10 |
| Varta Easypack XL Lithium Polymer Batteries (P/N 41772 and 42215) Used with: Nova Biomedic recall (Z-1472-2008) | Nova Biomedical Corporation | 2008-09-23 |