The following data is part of a premarket notification filed by Volu Sol Medical Industries with the FDA for Agglutinotest-infectious Mononucleosis.
Device ID | K791455 |
510k Number | K791455 |
Device Name: | AGGLUTINOTEST-INFECTIOUS MONONUCLEOSIS |
Classification | System, Test, Infectious Mononucleosis |
Applicant | VOLU SOL MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KTN |
CFR Regulation Number | 866.5640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-08-06 |
Decision Date | 1979-12-31 |