The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set.
| Device ID | K143470 |
| 510k Number | K143470 |
| Device Name: | Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set |
| Classification | Test, Fibrinogen |
| 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 | GIS |
| Subsequent Product Code | GFX |
| Subsequent Product Code | GIL |
| CFR Regulation Number | 864.7340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-05 |
| Decision Date | 2016-01-31 |
| Summary: | summary |