CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY
FDA 510(k) clearance K982680 · decided 1998-10-15
Clearance details
- K-number
- K982680
- Device name
- CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY
- Applicant
- Chiron Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1998-07-31
- Decision date
- 1998-10-15
- Days to decision
- 76 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 |
|---|---|---|
| Siemens Healthcare BR Assay for CA 27.29 250 Test Kits 03896216 50 Test Kit 02419937 Ref K recall (Z-0507-2013) | Siemens Healthcare Diagnostics, Inc | 2012-12-11 |
| Siemens Healthcare ADVIA Centaur Theophylline 2 (THE02) 250 Test 08838753 50 Test 03009619 recall (Z-0512-2013) | Siemens Healthcare Diagnostics, Inc | 2012-12-11 |
| Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests); RE recall (Z-0162-2013) | Siemens Healthcare Diagnostics, Inc | 2012-10-28 |