The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme D-dimer Assay Kit,calibrator Setand Control Set.
| Device ID | K112120 |
| 510k Number | K112120 |
| Device Name: | DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET |
| Classification | Fibrin Split Products |
| 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 | GHH |
| Subsequent Product Code | DAP |
| Subsequent Product Code | JIT |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-25 |
| Decision Date | 2013-01-24 |
| Summary: | summary |