Medical Device Manufacturer · US , Medfield , MA

Chiron Diagnostics Corp.

20 submissions · 20 cleared · Since 1997
20
Total
20
Cleared
0
Denied

Chiron Diagnostics Corp. — FDA 510(k) Submissions

Chiron Diagnostics Corp. has submitted 20 FDA 510(k) premarket notifications since 1997, of which 20 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Multi-analyte Controls, All Kinds (assayed), System, Test, Immunological, Antigen, Tumor, Radioimmunoassay, Total Triiodothyronine, Enzyme Immunoassay, Digitoxin, Ferritin, Antigen, Antiserum, Control . Use the specialty filter in the sidebar to narrow results.

20 devices
1–12 of 20
CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY
K992157 · DBF Ferritin, Antigen,... · Immunology
Aug 1999 41d
CHIRON DIAGNOSTICS ACS: 180 FOLATE
K991582 · CGN Acid, Folic,... · Immunology
Jun 1999 54d
CHIRON DIAGNOSTICS ACS: 180 FT3
K991692 · CDP Radioimmunoassay, Total... · Chemistry
Jun 1999 31d
CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY
K982680 · MOI System, Test,... · Immunology
Oct 1998 76d
ACS:CENTAUR CEA
K981478 · DHX System, Test,... · Immunology
Aug 1998 110d
ACS:CENTAUR PSA2 IMMUNOASSAY
K981839 · LTJ Prostate-specific Antigen... · Immunology
Aug 1998 78d
ACS:CENTAUR AFP
K981592 · LOQ Device, General Purpose,... · Immunology
Jul 1998 64d
CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI)
K980528 · MMI Immunoassay Method,... · Chemistry
Mar 1998 20d
ACS TOBRAMYCIN
K974029 · LCR Fluorescent Immunoassay,... · Toxicology
Feb 1998 112d
CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN
K974325 · DDR Myoglobin, Antigen,... · Chemistry
Dec 1997 20d
ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29)
K970695 · MOI System, Test,... · Immunology
Aug 1997 164d
CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER
K971418 · MOI System, Test,... · Chemistry
Jul 1997 92d
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