FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS
K Number: K013203
·
Decision Nov 16, 2001
Classifications
1
FEI Numbers
177
Registration Numbers
178
Same Product Code
506
Applicant Total
26
Review Days
52
Basic Information
- Device Name
- BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS
- K Number
- K013203
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- POLYMER TECHNOLOGY SYSTEMS, INC.
- Date Received
- September 25, 2001
- Decision Date
- November 16, 2001
- 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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|---|---|---|---|
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| 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 |