Diazyme Lp(A) Assay
FDA 510(k) K082488 · General Atomics
510(k) numberK082488
Submission
- Device name
- Diazyme Lp(A) Assay
- Applicant
- General Atomics
Poway, CA, US - Received
- August 28, 2008
- Decision date
- January 13, 2009
- 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
Other 510(k)s with product code DFC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253069 | Lipoprotein (a) Molarity AssayDFC · Traditional | Diazyme Laboratories, Inc. | 06/16/2026SE |
| K241220 | Tina-quant Lipoprotein(a) Gen.2 MolarityDFC · Traditional | Roche Diagnostics Operations | 01/24/2025SE |
| K211058 | Lp(a) UltraDFC · Traditional | SENTINEL CH. SpA | 12/22/2022SE |
| K180074 | Diazyme Lipoprotein (a) AssayDFC · Traditional | Diazyme Laboratories, Inc. | 03/22/2018SE |
| K123046 | Advia Chemistry Lipoprotein(A) Reagent Advia Chemistry Lipoprotein(A) CalibratorDFC · Traditional | Siemens Healthcare Diagnostics, Inc. | 12/20/2012SE |
| K122722 | Cobas C Tina-Quant Lipoprotein (a) Gen 2 Assay Model 05852625190; Preciset LP (a) Gen 2…DFC · Traditional | Roche Diagnostics | 11/29/2012SE |
| 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 |
More from Kamiya Biomedical Co.
| 510(k) | Device | Decision |
|---|---|---|
| K072977 | Diazyme Apolipoprotein A-1 AssayMSJ · Traditional | 07/16/2008SE |
| K072523 | Diazyme Ldl-Cholesterol Reagent, Calibrator and ControlsLBR · Traditional | 01/22/2008SE |
| K050178 | HBA1C Enzymatic AssayLCP · Traditional | 06/28/2005SE |
| K042448 | Diazyme Homocysteine Enzymatic Assay KitJJX · Traditional | 10/29/2004SE |
| K033360 | Diazyme Lithium Enzymatic Assay KitJII · Traditional | 12/23/2003SE |
Questions and answers
When was Diazyme Lp(A) Assay cleared by the FDA?
Diazyme Lp(A) Assay (K082488) received a 510(k) decision of Substantially Equivalent on January 13, 2009, 138 days after the submission was received.
What is the product code of K082488?
The FDA product code is DFC – Lipoprotein, Low-Density, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5600.