The following data is part of a premarket notification filed by Lifestream Technologies, Inc. with the FDA for Resolution Cholesterol Monitor.
| Device ID | K000610 |
| 510k Number | K000610 |
| Device Name: | RESOLUTION CHOLESTEROL MONITOR |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | LIFESTREAM TECHNOLOGIES, INC. 51O CLEARWATER LOOP, SUITE 101 Post Falls, ID 83854 |
| Contact | Jack Connolly |
| Correspondent | Jack Connolly LIFESTREAM TECHNOLOGIES, INC. 51O CLEARWATER LOOP, SUITE 101 Post Falls, ID 83854 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-23 |
| Decision Date | 2000-07-21 |