The following data is part of a premarket notification filed by Cholestech Corp. with the FDA for L.d.x Lipid Monitoring System.
| Device ID | K901900 |
| 510k Number | K901900 |
| Device Name: | L.D.X LIPID MONITORING SYSTEM |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | CHOLESTECH CORP. 3347 INVESTMENT BLVD. Hayward, CA 94545 |
| Contact | Gary Hewett |
| Correspondent | Gary Hewett CHOLESTECH CORP. 3347 INVESTMENT BLVD. Hayward, CA 94545 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-27 |
| Decision Date | 1990-07-24 |