MESA BIOTECH, INC

FDA Regulatory Profile

MESA BIOTECH, INC appears in FDA public data with 1 recall — including 1 Class I (most serious) —, 3 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-1009-2022, Class I) was initiated on April 6, 2022. Its most recent 510(k) clearance was granted on November 9, 2020.

Summary

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

Recent Recalls

NumberClassProductDate
Z-1009-2022Class IAccula SARS-CoV-2 Test, REF: COV4100April 6, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K201269Accula Strep A TestNovember 9, 2020
K181443Accula RSV TestNovember 23, 2018
K171641Accula Flu A/Flu B TestFebruary 6, 2018