Cellestis Inc

FDA Regulatory Profile

Cellestis Inc appears in FDA public data with 2 recalls, 0 510(k) clearances, 3 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0889-2013, Class II) was initiated on September 27, 2012.

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
3
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0889-2013Class IIVacuette Cellestis 1 ml QuantiFERON¿ TB ANTIGEN (HA) High Altitude: Shake 10x; REF 454413. HE0396. gSeptember 27, 2012
Z-0888-2013Class IIVACUETTE Cellestis 1 ml QuantiFERON¿ - TB ANTIGEN; Shake 10x; REF 454074; HE0105; 13X75 50 pcs.,1200September 27, 2012