ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080
FDA 510(k) clearance K062058 · decided 2006-09-11
Clearance details
- K-number
- K062058
- Device name
- ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080
- Applicant
- Bayer Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2006-07-20
- Decision date
- 2006-09-11
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- NBW
- 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
+ Add to Predicate Builder ◉ Watch Bayer Healthcare
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Contour, Contour TS Blood Glucose Test Strips and Bonus Packs Intended for self-testing by recall (Z-3268-2011) | Bayer Healthcare, LLC | 2011-09-19 |
| Ascensia Contour Blood Glucose Monitoring System ( Bayer )Diabetes Care System; Product 71 recall (Z-1001-2007) | Bayer Healthcare LLC | 2007-07-03 |
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 |