BIOSCANNER 2000
FDA 510(k) clearance K013068 · decided 2001-11-20
Clearance details
- K-number
- K013068
- Device name
- BIOSCANNER 2000
- Applicant
- Polymer Technology Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-06-28
- Decision date
- 2001-11-20
- Days to decision
- 145 days
- Clearance type
- Traditional
- Product code
- CGA
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage: use recall (Z-1403-2013) | Polymer Technology Systems, Inc. | 2013-05-25 |