Cirrus Diagnostics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
10
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K921704IMMULITE(R) FSHJune 9, 1992
K920411IMMULITE HLHMarch 11, 1992
K914833IMMULITE DIGOXINNovember 22, 1991
K911796IMMULITE(TM) HCGJune 20, 1991
K910677IMMULITE(TM) T-UPTAKEApril 29, 1991
K910261IMMULITE(TM) TOTAL T4April 16, 1991
K905648CRP LIPID REAGENT TEST PACKMarch 6, 1991
K905214IMMULITE (TM) TOTAL T3February 1, 1991
K905769IMMULITE HS-TSHJanuary 31, 1991
K905215IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZERJanuary 11, 1991