Archiect Insulin and Controls, Model 8K41-01, 8K41-10
FDA 510(k) K060359 · Denka Seiken Co., Ltd.
510(k) numberK060359
Submission
- Device name
- Archiect Insulin and Controls, Model 8K41-01, 8K41-10
- Applicant
- Denka Seiken Co., Ltd.
Gosen-Shi, Niigata, JP - Received
- February 13, 2006
- Decision date
- April 14, 2006
- 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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| K161679 | s LDL-EX SEIKENPYP · Traditional | 08/18/2017SE |
| K043264 | Ldl-Ex Seiken Assay KitMRR · Traditional | 01/26/2005SE |
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| K030545 | Crp-Latex (II)X2 Seiken Assay KitDCK · Traditional | 06/02/2003SE |
Questions and answers
When was Archiect Insulin and Controls, Model 8K41-01, 8K41-10 cleared by the FDA?
Archiect Insulin and Controls, Model 8K41-01, 8K41-10 (K060359) received a 510(k) decision of Substantially Equivalent on April 14, 2006, 60 days after the submission was received.
What is the product code of K060359?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.