The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Fibrinogen Determination Kit.
| Device ID | K913061 |
| 510k Number | K913061 |
| Device Name: | FIBRINOGEN DETERMINATION KIT |
| Classification | Test, Fibrinogen |
| Applicant | SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Contact | Daniel E Lawson |
| Correspondent | Daniel E Lawson SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Product Code | GIS |
| CFR Regulation Number | 864.7340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-10 |
| Decision Date | 1991-10-09 |