Home / Companies / Chiron Diagnostics Corp.

Chiron Diagnostics Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
20
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K992157CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAYAugust 5, 1999
K991582CHIRON DIAGNOSTICS ACS: 180 FOLATEJune 30, 1999
K991692CHIRON DIAGNOSTICS ACS: 180 FT3June 18, 1999
K982680CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAYOctober 15, 1998
K981839ACS:CENTAUR PSA2 IMMUNOASSAYAugust 12, 1998
K981478ACS:CENTAUR CEAAugust 12, 1998
K981592ACS:CENTAUR AFPJuly 7, 1998
K980528CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI)March 3, 1998
K974029ACS TOBRAMYCINFebruary 12, 1998
K974325CHIRON DIAGNOSTICS ACS:180 MYOGLOBINDecember 8, 1997
K970695ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29)August 8, 1997
K971418CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZERJuly 17, 1997
K970546ACS DIGITOXINJuly 14, 1997
K971405SPECIALITY URINE 1,2June 16, 1997
K970386ACS ESTADIOL-6 IIJune 4, 1997
K971071LIQUID LIGAND 1,2,3April 23, 1997
K970956CERTAIN COMPLETE LEVELS 1,2, AND 3; CVM LEVELS 1,2,3,4, AND 5April 8, 1997
K970979LIQUID CSF(LCR)1, LIQUID CSF(LCR)2April 2, 1997
K970539CHIRON DIAGNOSTICS ACS:180TU PMarch 24, 1997
K964765CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAYFebruary 14, 1997