The following data is part of a premarket notification filed by Cholestech Corp. with the FDA for Choletech Ldx High-sensitivity C-reactive Protein (hs-crp).
| Device ID | K040579 |
| 510k Number | K040579 |
| Device Name: | CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP) |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | CHOLESTECH CORP. 3347 INVESTMENT BLVD. Hayward, CA 94545 |
| Contact | Thomas E Worthy |
| Correspondent | Thomas E Worthy CHOLESTECH CORP. 3347 INVESTMENT BLVD. Hayward, CA 94545 |
| Product Code | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-04 |
| Decision Date | 2004-06-18 |
| Summary: | summary |