Wako Autokit Lp(A)/Express 550
FDA 510(k) K001921 · Wako Chemicals USA, Inc.
510(k) numberK001921
Submission
- Device name
- Wako Autokit Lp(A)/Express 550
- Applicant
- Wako Chemicals USA, Inc.
Richmond, VA, US - Received
- June 23, 2000
- Decision date
- July 23, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
More from Kamiya Biomedical Co.
| 510(k) | Device | Decision |
|---|---|---|
| K100464 | Utaswako I30 (Includes Accessories), Utaswako AFP-L3, Calibrator Set, Control L, Control…NSF · Traditional | 02/23/2011SE |
| K080125 | Apolowako T-Cho, Hdl-C, TG and Analyzer, Models 993-23501, 999-23601, 995-23701 and…LBS · Traditional | 07/18/2008SE |
| K080123 | Apolowako HBA1C, Glucose and Analyzer, Models 993-24601, 991-24401 and 993-25201CFR · Traditional | 07/17/2008SE |
| K061775 | Wako L-Type Creatinine-M Test, and Wako Creatinine CalibratorJFY · Traditional | 02/23/2007SE |
| K062368 | Wako Lba DCP Test System, Model 993-05301; DCP Control Set, Model 995-0551; DCP…OAU · Traditional | 01/31/2007SE |
| K053132 | Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691, 998-23791JFM · Traditional | 12/30/2005SE |
| K053131 | Wako Total Bilirubin V, Models 410-22701, 998-23291, 416-22801, 990-23191JFM · Traditional | 12/30/2005SE |
| K042551 | Multi-Chem Calibrator aJIX · Traditional | 11/16/2004SE |
| K042550 | Multi-Lipid CalibratorJIX · Traditional | 11/08/2004SE |
| K042549 | Multi Chem Cal BJIX · Traditional | 11/08/2004SE |
Questions and answers
When was Wako Autokit Lp(A)/Express 550 cleared by the FDA?
Wako Autokit Lp(A)/Express 550 (K001921) received a 510(k) decision of Substantially Equivalent on July 23, 2000, 30 days after the submission was received.
What is the product code of K001921?
The FDA product code is DFC – Lipoprotein, Low-Density, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5600.