CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k) clearance K111268 · decided 2012-03-06
Clearance details
- K-number
- K111268
- Device name
- CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM
- Applicant
- Bayer Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2011-05-04
- Decision date
- 2012-03-06
- Days to decision
- 307 days
- Clearance type
- Traditional
- Product code
- LFR
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mishawaka, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Contour Next Control Solution for Contour Next Blood Glucose Test System. Liquid quality c recall (Z-2482-2015) | Bayer Healthcare, LLC | 2015-08-29 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BIOSTATOR GCIIS (P790028/S002) | Bayer Healthcare | 1983-08-08 |
| BIOSTATOR GCIIS (P790028/S001) | Bayer Healthcare | 1982-11-18 |
| BIOSTATOR GCIIS (P790028) | Bayer Healthcare | 1980-12-04 |