Chiron Diagnostics Corp.
Medfield, MA, US
Chiron Diagnostics Corp. appears in FDA device records in Medfield, MA. FDA records list 20 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 20
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 20 510(k) clearances for Chiron Diagnostics Corp. between 1997 and 1999. The busiest year on record is 1997, with 11. The most recent is 1999, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 11 |
| 1998 | 6 |
| 1999 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K992157 | CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY | DBF | Substantially Equivalent | |
| K991582 | CHIRON DIAGNOSTICS ACS: 180 FOLATE | CGN | Substantially Equivalent | |
| K991692 | CHIRON DIAGNOSTICS ACS: 180 FT3 | CDP | Substantially Equivalent | |
| K982680 | CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY | MOI | Substantially Equivalent | |
| K981839 | ACS:CENTAUR PSA2 IMMUNOASSAY | LTJ | Substantially Equivalent | |
| K981478 | ACS:CENTAUR CEA | DHX | Substantially Equivalent | |
| K981592 | ACS:CENTAUR AFP | LOQ | Substantially Equivalent | |
| K980528 | CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI) | MMI | Substantially Equivalent | |
| K974029 | ACS TOBRAMYCIN | LCR | Substantially Equivalent | |
| K974325 | CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN | DDR | Substantially Equivalent | |
| K970695 | ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) | MOI | Substantially Equivalent | |
| K971418 | CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER | MOI | Substantially Equivalent | |
| K970546 | ACS DIGITOXIN | LFM | Substantially Equivalent | |
| K971405 | SPECIALITY URINE 1,2 | JJY | Substantially Equivalent | |
| K970386 | ACS ESTADIOL-6 II | CHP | Substantially Equivalent | |
| K971071 | LIQUID LIGAND 1,2,3 | JJY | Substantially Equivalent | |
| K970956 | CERTAIN COMPLETE LEVELS 1,2, AND 3; CVM LEVELS 1,2,3,4, AND 5 | JJY | Substantially Equivalent | |
| K970979 | LIQUID CSF(LCR)1, LIQUID CSF(LCR)2 | JJY | Substantially Equivalent | |
| K970539 | CHIRON DIAGNOSTICS ACS:180TU P | KHQ | Substantially Equivalent | |
| K964765 | CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY | KLT | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CGNAcid, Folic, Radioimmunoassay
- LOQDevice, General Purpose, Hematology
- KLTEnzyme Immunoassay, Carbamazepine
- LFMEnzyme Immunoassay, Digitoxin
- DBFFerritin, Antigen, Antiserum, Control
- LCRFluorescent Immunoassay, Tobramycin
- MMIImmunoassay Method, Troponin Subunit
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- DDRMyoglobin, Antigen, Antiserum, Control
- LTJProstate-Specific Antigen (Psa) For Management Of Prostate Cancers
- KHQRadioassay, Triiodothyronine Uptake
- CHPRadioimmunoassay, Estradiol
- CDPRadioimmunoassay, Total Triiodothyronine
- DHXSystem, Test, Carcinoembryonic Antigen
- MOISystem, Test, Immunological, Antigen, Tumor
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain