Abbott Architect Estradiol Calibrators; Abbott Imx Estradiol Calibrator; Abbott Imx Estradiol Mode 1 Calibrator; Abbott
FDA 510(k) K032458 · Abbott Laboratories
510(k) numberK032458
Submission
- Device name
- Abbott Architect Estradiol Calibrators; Abbott Imx Estradiol Calibrator; Abbott Imx Estradiol Mode 1 Calibrator; Abbott
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- August 11, 2003
- Decision date
- October 6, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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
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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 |
| K162538 | ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) CalibratorJIT · Special | Siemens Healthcare Diagnostics | 11/17/2016SE |
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Questions and answers
When was Abbott Architect Estradiol Calibrators; Abbott Imx Estradiol Calibrator; Abbott Imx Estradiol Mode 1 Calibrator; Abbott cleared by the FDA?
Abbott Architect Estradiol Calibrators; Abbott Imx Estradiol Calibrator; Abbott Imx Estradiol Mode 1 Calibrator; Abbott (K032458) received a 510(k) decision of Substantially Equivalent on October 6, 2003, 56 days after the submission was received.
What is the product code of K032458?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.