The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme Cystatin C: Assay Kit (dz133a-k), Calibrator (dz133a-cal), Controls (dz133a-con).
| Device ID | K072270 |
| 510k Number | K072270 |
| Device Name: | DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON) |
| Classification | Test, Cystatin C |
| Applicant | DIAZYME LABORATORIES 12889 GREGG COURT Poway, CA 92064 |
| Contact | Charles Yu |
| Correspondent | Charles Yu DIAZYME LABORATORIES 12889 GREGG COURT Poway, CA 92064 |
| Product Code | NDY |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-15 |
| Decision Date | 2008-02-01 |