510(k) K063852
K063852 is an FDA 510(k) premarket notification submitted by Home Access Health Corp. for the device "ACCESSA CHOLESTEROL PANEL". The FDA issued a decision of Substantially Equivalent on November 9, 2007. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Home Access Health Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 9, 2007
- Date Received
- December 28, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubes, Vials, Systems, Serum Separators, Blood Collection
- Device Class
- Class II
- Regulation Number
- 862.1675
- Review Panel
- CH
- Submission Type