The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Fibrinogen Control.
| Device ID | K915462 |
| 510k Number | K915462 |
| Device Name: | FIBRINOGEN CONTROL |
| Classification | Plasma, Fibrinogen Control |
| Applicant | SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Contact | Daniel Lawson |
| Correspondent | Daniel Lawson SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Product Code | GIL |
| CFR Regulation Number | 864.7340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-04 |
| Decision Date | 1992-03-04 |