The following data is part of a premarket notification filed by Lifestream Diagnostics, Inc. with the FDA for Cholestron Pro Ii Cholesterol Test.
| Device ID | K981345 |
| 510k Number | K981345 |
| Device Name: | CHOLESTRON PRO II CHOLESTEROL TEST |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | LIFESTREAM DIAGNOSTICS, INC. 575 Shirlynn Court Los Altos, CA 94022 |
| Contact | Erika B Ammirati |
| Correspondent | Erika B Ammirati LIFESTREAM DIAGNOSTICS, INC. 575 Shirlynn Court Los Altos, CA 94022 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-14 |
| Decision Date | 1998-10-01 |
| Summary: | summary |