Chiron Diagnostics Corp. - FDA 510(k) Cleared Devices
20
Total
20
Cleared
0
Denied
FDA 510(k) Regulatory Record - Chiron Diagnostics Corp. Chemistry ✕
11 devices
Cleared
Jun 18, 1999
CHIRON DIAGNOSTICS ACS: 180 FT3
Chemistry
31d
Cleared
Mar 03, 1998
CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI)
Chemistry
20d
Cleared
Dec 08, 1997
CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN
Chemistry
20d
Cleared
Jul 17, 1997
CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER
Chemistry
92d
Cleared
Jul 14, 1997
ACS DIGITOXIN
Chemistry
152d
Cleared
Jun 16, 1997
SPECIALITY URINE 1,2
Chemistry
61d
Cleared
Jun 04, 1997
ACS ESTADIOL-6 II
Chemistry
121d
Cleared
Apr 23, 1997
LIQUID LIGAND 1,2,3
Chemistry
30d
Cleared
Apr 08, 1997
CERTAIN COMPLETE LEVELS 1,2, AND 3
Chemistry
22d
Cleared
Apr 02, 1997
LIQUID CSF(LCR)1, LIQUID CSF(LCR)2
Chemistry
16d
Cleared
Mar 24, 1997
CHIRON DIAGNOSTICS ACS:180TU P
Chemistry
40d