The following data is part of a premarket notification filed by Cholestech Corp. with the FDA for Total Cholesterol Cassette.
| Device ID | K946064 |
| 510k Number | K946064 |
| Device Name: | TOTAL CHOLESTEROL CASSETTE |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | CHOLESTECH CORP. 3347 INVESTMENT BLVD. Hayward, CA 94545 |
| Contact | Gery Hewett |
| Correspondent | Gery 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 | 1994-11-15 |
| Decision Date | 1995-02-22 |