The following data is part of a premarket notification filed by Bio/data Corp. with the FDA for Low Fibrinogen Control.
| Device ID | K812108 |
| 510k Number | K812108 |
| Device Name: | LOW FIBRINOGEN CONTROL |
| Classification | System, Fibrinogen Determination |
| Applicant | BIO/DATA CORP. 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 | 1981-07-27 |
| Decision Date | 1981-09-24 |