CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER
FDA 510(k) clearance K971418 · decided 1997-07-17
Clearance details
- K-number
- K971418
- Device name
- CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER
- Applicant
- Chiron Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-04-16
- Decision date
- 1997-07-17
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- MOI
- Device class
- 2
- Regulation number
- 866.6010
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Medfield, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ADVIA Centaur XP Immunoassay system, an automated in vitro diagnostic analyzer. Catalog # recall (Z-1553-2014) | Siemens Healthcare Diagnostics | 2014-05-13 |
| ADVIA Centaur HAV IgM, 100 Test Kit, used on the ADVIA Centaur or XP, REF: 05004126, in vi recall (Z-1119-2008) | Siemens Medical Solutions Diagnostics | 2008-05-06 |
| ADVIA Centaur CP System, Catalog/Part Number 086-A001. Automated Immunoassay Analyzer. --- recall (Z-0645-2007) | Siemens Healthcare Diagnostics | 2007-03-22 |
| ADVIA Centaur CP System, Automated Immunoassay Analyzer, Part /Catalogue Number 086-A001. recall (Z-1516-06) | Siemens Healthcare Diagnostics | 2006-09-23 |