The following data is part of a premarket notification filed by Volu Sol Medical Industries with the FDA for Digiclot 2-#820.
| Device ID | K812121 |
| 510k Number | K812121 |
| Device Name: | DIGICLOT 2-#820 |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | VOLU SOL MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-27 |
| Decision Date | 1981-11-16 |