ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator
FDA 510(k) clearance K162538 · decided 2016-11-17
Clearance details
- K-number
- K162538
- Device name
- ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator
- Applicant
- Siemens Healthcare Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2016-09-12
- Decision date
- 2016-11-17
- Days to decision
- 66 days
- Clearance type
- Special
- Product code
- JIT
- Device class
- 2
- Regulation number
- 862.1150
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- East Walpole, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Atellica IM Hepatitis B core IgM (aHBcM) (P030040/S024) | Siemens Healthcare Diagnostics | 2025-10-17 |
| Atellica IM Hepatitis B e Antigen (HBeAg) (P090024/S013) | Siemens Healthcare Diagnostics | 2025-10-17 |
| ADVIA Centaur® PSA Immunoassay; Atellica IM Prostate-Specific Antigen (PSA) (P950021/S030) | Siemens Healthcare Diagnostics | 2025-07-16 |
| ADVIA Centaur® Complexed PSA (cPSA) Immunoassay; Atellica IM Complexed Prostate-Specific Antigen (cPSA) (P990055/S029) | Siemens Healthcare Diagnostics | 2025-07-16 |
| Dimension TPSA Flex reagent cartridge (P000021/S047) | Siemens Healthcare Diagnostics | 2025-05-22 |
| Dimension FPSA Flex reagent cartridge (P020027/S042) | Siemens Healthcare Diagnostics | 2025-05-22 |
| Dimension FPSA Flex reagent cartridge (P020027/S041) | Siemens Healthcare Diagnostics | 2025-02-24 |
| Dimension TPSA Flex reagent cartridge (P000021/S046) | Siemens Healthcare Diagnostics | 2025-02-24 |