FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM
K Number: K140068
·
Decision May 22, 2015
Classifications
1
FEI Numbers
168
Registration Numbers
169
Same Product Code
507
Applicant Total
27
Review Days
494
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Basic Information
- Device Name
- CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM
- K Number
- K140068
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Polymer Technology Systems, Inc.
- Date Received
- January 13, 2014
- Decision Date
- May 22, 2015
- Product Code
- NBW
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | FDA class 2 | Clinical Chemistry |
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Other Clearances by Polymer Technology Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K151545 | CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System | Dec 22, 2016 | Substantially Equivalent |
| K151530 | CardioChek Plus Test System | Jul 7, 2015 | Substantially Equivalent |
| K142302 | BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test System | Oct 2, 2014 | Substantially Equivalent |
| K071593 | PTS PANELS CHOL+HDL PANEL TEST STRIPS | Oct 15, 2007 | Substantially Equivalent |
| K071507 | PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS | Sep 10, 2007 | Substantially Equivalent |
| K070017 | PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPS | Jan 31, 2007 | Substantially Equivalent |
| K060617 | PTS PANELS HDL CHOLESTEROL TEST STRIPS | Apr 5, 2006 | Substantially Equivalent |
| K041750 | PTS PANELS CHOL+GLU TEST PANEL | Jul 23, 2004 | Substantially Equivalent |
| K040693 | PTS PANELS LDL CHOLESTEROL TEST STRIPS | Jul 6, 2004 | Substantially Equivalent |
| K023558 | PTS PANELS LIPID PANEL TEST STRIPS | Nov 15, 2002 | Substantially Equivalent |