Product Code: NAQ
FDA class 1
21 CFR 862.1175
Lipoprotein, High Density, Hdl, Over The Counter
Clinical Chemistry
The Over-The-Counter High Density Lipoprotein (HDL) Test is a clinical chemistry diagnostic device designed for consumer use to measure HDL cholesterol levels in blood, which is an important indicator of cardiovascular health and risk. Classified as FDA Class 1, it is subject to general controls under regulation 862.1175 (Clinical Chemistry specialty). This device is eligible for third-party 510(k) review.
510(k)s
2
FEI Numbers
3
Registration Numbers
3
Unique Applicants
1
Years Active
6
Basic Information
- Product Code
- NAQ
- Device Class
- FDA class 1
- Regulation Number
- 862.1175
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K060617 | PTS PANELS HDL CHOLESTEROL TEST STRIPS | Apr 05, 2006 | Substantially Equivalent | POLYMER TECHNOLOGY SYSTEMS, INC. |
| K993377 | MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC) | Jan 13, 2000 | Substantially Equivalent | POLYMER TECHNOLOGY SYSTEMS, INC. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.