The following data is part of a premarket notification filed by Volu Sol Medical Industries with the FDA for Elvi Biclot 816.
| Device ID | K812906 |
| 510k Number | K812906 |
| Device Name: | ELVI BICLOT 816 |
| Classification | Instrument, Coagulation |
| Applicant | VOLU SOL MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KQG |
| CFR Regulation Number | 864.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-19 |
| Decision Date | 1982-07-22 |