Advia Chemistry Lipoprotein(A) Reagent Advia Chemistry Lipoprotein(A) Calibrator
FDA 510(k) K123046 · Siemens Healthcare Diagnostics, Inc.
510(k) numberK123046
Submission
- Device name
- Advia Chemistry Lipoprotein(A) Reagent Advia Chemistry Lipoprotein(A) Calibrator
- Applicant
- Siemens Healthcare Diagnostics, Inc.
Tarrytown, NY, US - Received
- September 28, 2012
- Decision date
- December 20, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DFC – Lipoprotein, Low-Density, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5600
- Specialty
- Immunology
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| K122722 | Cobas C Tina-Quant Lipoprotein (a) Gen 2 Assay Model 05852625190; Preciset LP (a) Gen 2…DFC · Traditional | Roche Diagnostics | 11/29/2012SE |
| K082488 | Diazyme Lp(A) AssayDFC · Traditional | General Atomics | 01/13/2009SE |
| K063838 | Lipoprotein(A), Lipoprotein(A) Calibrator, Lipoprotein (a) Control, Control HighDFC · Traditional | Thermo Electron OY | 09/27/2007SE |
| K050487 | Quantia La(A)DFC · Traditional | Biokit, S.A. | 04/26/2005SE |
| K023853 | K-Assay Lp(A) ControlsDFC · Traditional | Kamiya Biomedical Co. | 12/13/2002SE |
| K021660 | K-Assay Lp(A) AssayDFC · Traditional | Kamiya Biomedical Co. | 07/25/2002SE |
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Questions and answers
When was Advia Chemistry Lipoprotein(A) Reagent Advia Chemistry Lipoprotein(A) Calibrator cleared by the FDA?
Advia Chemistry Lipoprotein(A) Reagent Advia Chemistry Lipoprotein(A) Calibrator (K123046) received a 510(k) decision of Substantially Equivalent on December 20, 2012, 83 days after the submission was received.
What is the product code of K123046?
The FDA product code is DFC – Lipoprotein, Low-Density, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5600.