Accessa Cholesterol Panel
by Home Access Health Corporation
510(k) K063852
Accessa Cholesterol Panel is a medical device (FDA Class II; FDA product code JKA, Tubes, Vials, Systems, Serum Separators, Blood Collection) made by Home Access Health Corporation, cleared under FDA 510(k) K063852 on 9 Nov 2007, active as of 8 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK063852 | Date9 Nov 2007 | StatusActive |
Official records
- FDA 510(k) database K063852
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JKA
- FDA applicant
- Home Access Health Corp.
- Device class
- Class II
- Regulation
- 21 CFR Part 862.1675
- Advisory committee
- Clinical Chemistry
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K063852
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| CHECK UP AMERICA CHOLESTEROL PANEL 80 | 80 | M769CHOLESTEROL801 | — | On the market |
| CHECK UP AMERICAL CHOLESTEROL PANEL 81 | 81 | M769CHOLESTEROL811 | — | On the market |
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