The following data is part of a premarket notification filed by Cholestech Corp. with the FDA for Cholestech L.d.x. Lipid Analyzer, Modification.
| Device ID | K911578 |
| 510k Number | K911578 |
| Device Name: | CHOLESTECH L.D.X. LIPID ANALYZER, MODIFICATION |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | CHOLESTECH CORP. 3347 INVESTMENT BLVD. Hayward, CA 94545 |
| Contact | Lynn Banfield |
| Correspondent | Lynn Banfield 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 | 1991-03-27 |
| Decision Date | 1991-05-15 |