The following data is part of a premarket notification filed by Haemachem, Inc. with the FDA for Fibrinotest(tm) - Fibrinogen Assay.
| Device ID | K903874 |
| 510k Number | K903874 |
| Device Name: | FIBRINOTEST(TM) - FIBRINOGEN ASSAY |
| Classification | Test, Fibrinogen |
| Applicant | HAEMACHEM, INC. 2335 SOUTH HANLEY RD. St. Louis, MO 63144 |
| Contact | Thye Yin |
| Correspondent | Thye Yin HAEMACHEM, INC. 2335 SOUTH HANLEY RD. St. Louis, MO 63144 |
| Product Code | GIS |
| CFR Regulation Number | 864.7340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-22 |
| Decision Date | 1991-02-14 |