The following data is part of a premarket notification filed by Cholestech Corp. with the FDA for Cholestech Ldx System.
| Device ID | K954778 |
| 510k Number | K954778 |
| Device Name: | CHOLESTECH LDX SYSTEM |
| Classification | Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
| Applicant | CHOLESTECH CORP. 3347 INVESTMENT BLVD. Hayward, CA 94545 |
| Contact | Gary E Hewett |
| Correspondent | Gary E Hewett CHOLESTECH CORP. 3347 INVESTMENT BLVD. Hayward, CA 94545 |
| Product Code | LBS |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JGY |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-19 |
| Decision Date | 1995-11-24 |