PTS PANELS LIPID PANEL TEST STRIPS
FDA 510(k) clearance K022898 · decided 2002-09-24
Clearance details
- K-number
- K022898
- Device name
- PTS PANELS LIPID PANEL TEST STRIPS
- Applicant
- Polymer Technology Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-09-03
- Decision date
- 2002-09-24
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- CHH
- Device class
- 1
- Regulation number
- 862.1175
- 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 Lipids Panel test strips for self-testing or professional use with CardioChek P recall (Z-1136-2010) | Polymer Technology Systems, Inc. | 2010-03-15 |