CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM
FDA 510(k) clearance K091820 · decided 2009-08-26
Clearance details
- K-number
- K091820
- Device name
- CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM
- Applicant
- Bayer Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2009-06-18
- Decision date
- 2009-08-26
- Days to decision
- 69 days
- Clearance type
- Special
- 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
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Recalls involving this device
No recalls on record reference this clearance.
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 |