PTS PANELS HDL CHOLESTEROL TEST STRIPS
FDA 510(k) clearance K060617 · decided 2006-04-05
Clearance details
- K-number
- K060617
- Device name
- PTS PANELS HDL CHOLESTEROL TEST STRIPS
- Applicant
- Polymer Technology Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-03-08
- Decision date
- 2006-04-05
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- NAQ
- 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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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC) (K993377) | Polymer Technology Systems, Inc. | 2000-01-13 |
Recalls involving this device
No recalls on record reference this clearance.