The following data is part of a premarket notification filed by Cala Diagnostics with the FDA for Fibrinogen Fdp Control.
| Device ID | K915503 |
| 510k Number | K915503 |
| Device Name: | FIBRINOGEN FDP CONTROL |
| Classification | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control |
| Applicant | CALA DIAGNOSTICS P.O. BOX 6714 Los Osos, CA 93412 |
| Contact | James F Godfrey |
| Correspondent | James F Godfrey CALA DIAGNOSTICS P.O. BOX 6714 Los Osos, CA 93412 |
| Product Code | DAP |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-09 |
| Decision Date | 1992-01-30 |