The following data is part of a premarket notification filed by Cholestech Corp. with the FDA for Cholestech L.d.x. System.
| Device ID | K932727 |
| 510k Number | K932727 |
| Device Name: | CHOLESTECH L.D.X. SYSTEM |
| Classification | Glucose Oxidase, Glucose |
| 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 | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-04 |
| Decision Date | 1993-11-09 |