The following data is part of a premarket notification filed by Volu Sol Medical Industries with the FDA for Agglutinotest-syphilis.
| Device ID | K791457 |
| 510k Number | K791457 |
| Device Name: | AGGLUTINOTEST-SYPHILIS |
| Classification | Antigens, Ha, Treponema Pallidum |
| Applicant | VOLU SOL MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GMT |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-08-06 |
| Decision Date | 1979-09-24 |