Atossa Genetics, Inc.

FDA Regulatory Profile

Atossa Genetics, Inc. appears in FDA public data with 1 recall — including 1 Class I (most serious) —, 0 510(k) clearances, 2 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0042-2014, Class I) was initiated on September 19, 2013.

Summary

Total Recalls
1 (1 Class I)
510(k) Clearances
0
Inspections
2
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0042-2014Class IBrand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT SysSeptember 19, 2013