ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY
FDA 510(k) clearance K020217 · decided 2002-03-15
Clearance details
- K-number
- K020217
- Device name
- ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY
- Applicant
- Bayer Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-01-22
- Decision date
- 2002-03-15
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- JJX
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Tarrytown, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro di recall (Z-0173-2014) | Siemens Healthcare Diagnostics, Inc | 2013-11-06 |
| ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic use in calibrati recall (Z-1514-2013) | Siemens Healthcare Diagnostics, Inc | 2013-06-06 |
| ADVIA Centaur iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitro diagnostic use i recall (Z-1515-2013) | Siemens Healthcare Diagnostics, Inc | 2013-06-06 |
| ADVIA Centaur Intact PTH (iPTH) Assay -assay (lot 138) Cat. Nos. 100 Test kit 04385983 (12 recall (Z-1186-2012) | Siemens Healthcare Diagnostics, Inc | 2012-03-07 |