Tina-Quant Apolipoprotein B VER.2
FDA 510(k) K013207 · Roche Diagnostics Corp.
510(k) numberK013207
Submission
- Device name
- Tina-Quant Apolipoprotein B VER.2
- Applicant
- Roche Diagnostics Corp.
Indianapolis, IN, US - Received
- September 25, 2001
- Decision date
- November 13, 2001
- 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 |
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Questions and answers
When was Tina-Quant Apolipoprotein B VER.2 cleared by the FDA?
Tina-Quant Apolipoprotein B VER.2 (K013207) received a 510(k) decision of Substantially Equivalent on November 13, 2001, 49 days after the submission was received.
What is the product code of K013207?
The FDA product code is DFC – Lipoprotein, Low-Density, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5600.