The following data is part of a premarket notification filed by Volu Sol Medical Industries with the FDA for Agglutinotest-staphylolisin.
| Device ID | K791453 |
| 510k Number | K791453 |
| Device Name: | AGGLUTINOTEST-STAPHYLOLISIN |
| Classification | Antisera, Fluorescent, All Types, Staphylococcus Spp. |
| Applicant | VOLU SOL MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GTN |
| CFR Regulation Number | 866.3700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-08-06 |
| Decision Date | 1979-09-24 |