The following data is part of a premarket notification filed by Cholestech Corp. with the FDA for Cholestech L.d.x. Level 1 Control.
| Device ID | K904784 |
| 510k Number | K904784 |
| Device Name: | CHOLESTECH L.D.X. LEVEL 1 CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | CHOLESTECH CORP. 3347 INVESTMENT BLVD. Hayward, CA 94545 |
| Contact | Susan Willson |
| Correspondent | Susan Willson CHOLESTECH CORP. 3347 INVESTMENT BLVD. Hayward, CA 94545 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-22 |
| Decision Date | 1990-12-18 |