The following data is part of a premarket notification filed by Home Access Health Corp. with the FDA for Accessa Cholesterol Panel.
| Device ID | K063852 |
| 510k Number | K063852 |
| Device Name: | ACCESSA CHOLESTEROL PANEL |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | HOME ACCESS HEALTH CORP. 2401 W. HASSELL SUITE 1510 Hoffman Estates, IL 60195 -5200 |
| Contact | Karen L Hanson |
| Correspondent | Karen L Hanson HOME ACCESS HEALTH CORP. 2401 W. HASSELL SUITE 1510 Hoffman Estates, IL 60195 -5200 |
| Product Code | JKA |
| Subsequent Product Code | CHH |
| Subsequent Product Code | JGY |
| Subsequent Product Code | LBS |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-28 |
| Decision Date | 2007-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M769CHOLESTEROL811 | K063852 | 000 |
| M769CHOLESTEROL801 | K063852 | 000 |