CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System
FDA 510(k) clearance K151545 · decided 2016-12-22
Clearance details
- K-number
- K151545
- Device name
- CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System
- Applicant
- Polymer Technology Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-06-09
- Decision date
- 2016-12-22
- Days to decision
- 562 days
- Clearance type
- Traditional
- 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
No recalls on record reference this clearance.