The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme Hs Crp Assay Kit / Calibrator Set / Control Set.
| Device ID | K103557 |
| 510k Number | K103557 |
| Device Name: | DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | DIAZYME LABORATORIES 12889 GREGG COURT Poway, CA 92064 |
| Contact | Abhijit Datta |
| Correspondent | Abhijit Datta DIAZYME LABORATORIES 12889 GREGG COURT Poway, CA 92064 |
| Product Code | DCK |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-02 |
| Decision Date | 2011-04-27 |
| Summary: | summary |