FDA 510(k) Applications Submitted by CHIRON DIAGNOSTICS CORP.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K970695 |
02/25/1997 |
ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) |
CHIRON DIAGNOSTICS CORP. |
| K970979 |
03/17/1997 |
LIQUID CSF(LCR)1, LIQUID CSF(LCR)2 |
CHIRON DIAGNOSTICS CORP. |
| K971071 |
03/24/1997 |
LIQUID LIGAND 1,2,3 |
CHIRON DIAGNOSTICS CORP. |
| K971405 |
04/16/1997 |
SPECIALITY URINE 1,2 |
CHIRON DIAGNOSTICS CORP. |
| K970386 |
02/03/1997 |
ACS ESTADIOL-6 II |
CHIRON DIAGNOSTICS CORP. |
| K970546 |
02/12/1997 |
ACS DIGITOXIN |
CHIRON DIAGNOSTICS CORP. |
| K970956 |
03/17/1997 |
CERTAIN COMPLETE LEVELS 1,2, AND 3; CVM LEVELS 1,2,3,4, AND 5 |
CHIRON DIAGNOSTICS CORP. |
| K981478 |
04/24/1998 |
ACS:CENTAUR CEA |
CHIRON DIAGNOSTICS CORP. |
| K981592 |
05/04/1998 |
ACS:CENTAUR AFP |
CHIRON DIAGNOSTICS CORP. |
| K974029 |
10/23/1997 |
ACS TOBRAMYCIN |
CHIRON DIAGNOSTICS CORP. |
| K980528 |
02/11/1998 |
CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI) |
CHIRON DIAGNOSTICS CORP. |
| K970539 |
02/12/1997 |
CHIRON DIAGNOSTICS ACS:180TU P |
CHIRON DIAGNOSTICS CORP. |
| K971418 |
04/16/1997 |
CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER |
CHIRON DIAGNOSTICS CORP. |
| K991582 |
05/07/1999 |
CHIRON DIAGNOSTICS ACS: 180 FOLATE |
CHIRON DIAGNOSTICS CORP. |
| K991692 |
05/18/1999 |
CHIRON DIAGNOSTICS ACS: 180 FT3 |
CHIRON DIAGNOSTICS CORP. |
| K981839 |
05/26/1998 |
ACS:CENTAUR PSA2 IMMUNOASSAY |
CHIRON DIAGNOSTICS CORP. |
| K992157 |
06/25/1999 |
CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY |
CHIRON DIAGNOSTICS CORP. |
| K982680 |
07/31/1998 |
CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY |
CHIRON DIAGNOSTICS CORP. |
| K974325 |
11/18/1997 |
CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN |
CHIRON DIAGNOSTICS CORP. |
| K964765 |
11/27/1996 |
CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY |
CHIRON DIAGNOSTICS CORP. |
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