The following data is part of a premarket notification filed by Lifestream Technologies, Inc. with the FDA for Lifestream Plus Cholesterol Monitor, Modification To Resolution Cholesterol Monitor.
| Device ID | K033899 |
| 510k Number | K033899 |
| Device Name: | LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL MONITOR |
| Classification | Test, Cholesterol, Total, Over The Counter |
| Applicant | LIFESTREAM TECHNOLOGIES, INC. 510 CLEARWATER LOOP, SUITE 101 Post Falls, ID 83854 |
| Contact | Jackson Connolly |
| Correspondent | Jackson Connolly LIFESTREAM TECHNOLOGIES, INC. 510 CLEARWATER LOOP, SUITE 101 Post Falls, ID 83854 |
| Product Code | NFX |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-17 |
| Decision Date | 2004-05-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00381931790018 | K033899 | 000 |