ACCESSA CHOLESTEROL PANEL
FDA 510(k) clearance K063852 · decided 2007-11-09
Clearance details
- K-number
- K063852
- Device name
- ACCESSA CHOLESTEROL PANEL
- Applicant
- Home Access Health Corp.
- Decision
- Substantially Equivalent
- Date received
- 2006-12-28
- Decision date
- 2007-11-09
- Days to decision
- 316 days
- Clearance type
- Traditional
- Product code
- JKA
- Device class
- 2
- Regulation number
- 862.1675
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Hoffman Estates, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Home Access Health Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.