ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator
FDA 510(k) K162538 · Siemens Healthcare Diagnostics
510(k) numberK162538
Submission
- Device name
- ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator
- Applicant
- Siemens Healthcare Diagnostics
East Walpole, MA, US - Received
- September 12, 2016
- Decision date
- November 17, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JIT – Calibrator, Secondary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JIT
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|---|---|---|---|
| K171168 | VITROS Immunodiagnostic Products Insulin CalibratorsJIT · Abbreviated | Ortho Clinical Diagnostics | 05/16/2017SE |
| K170938 | CalSet IGF-1JIT · Traditional | Roche Diagnostics | 04/26/2017SE |
| K170160 | Abbott ARCHITECT Free T3JIT · Traditional | Abbott Laboratories | 02/15/2017SE |
| K163546 | Lumipulse G Progesterone-N CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/13/2017SE |
| K163534 | Lumipulse G FSH-N CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/13/2017SE |
| K163544 | Lumipulse G ProlactinJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/12/2017SE |
| K163521 | Lumipulse G LH CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/12/2017SE |
| K163078 | Dc-Uibc-CalJIT · Abbreviated | Sekisui Diagnostics P.E.I., Inc. | 12/08/2016SE |
| K163053 | Lumipulse G E2-III CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 12/01/2016SE |
| K160113 | ST AIA-PACK hsE2 Calibrator SetJIT · Traditional | Tosoh Bioscience, Inc. | 02/17/2016SE |
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Questions and answers
When was ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator cleared by the FDA?
ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator (K162538) received a 510(k) decision of Substantially Equivalent on November 17, 2016, 66 days after the submission was received.
What is the product code of K162538?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.