Iris Molecular Diagnostics

FDA Regulatory Profile

Iris Molecular Diagnostics appears in FDA public data with 0 recalls, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on September 20, 2011.

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K101185NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAYSeptember 20, 2011