The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Fibrinogen Assay Kit.
| Device ID | K841020 |
| 510k Number | K841020 |
| Device Name: | FIBRINOGEN ASSAY KIT |
| Classification | System, Fibrinogen Determination |
| Applicant | HELENA LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KQJ |
| CFR Regulation Number | 864.7340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-12 |
| Decision Date | 1984-05-02 |