INNOVA MEDICAL GROUP, INC.

FDA Regulatory Profile

Summary

Total Recalls
3 (3 Class I)
510(k) Clearances
0
Inspections
3
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1538-2021Class IFor In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid QualitaApril 9, 2021
Z-1539-2021Class ICOVID-19 Self-Test Kit *** INNOVA *** 3TApril 9, 2021
Z-1537-2021Class ICOVID-19 Self-Test Kit *** INNOVA *** 7TApril 9, 2021