Wako-Igg Ii-Ha, Immunoglobulin Calibrator Set, Immunolobulin Standard
FDA 510(k) K993928 · Wako Chemicals USA, Inc.
510(k) numberK993928
Submission
- Device name
- Wako-Igg Ii-Ha, Immunoglobulin Calibrator Set, Immunolobulin Standard
- Applicant
- Wako Chemicals USA, Inc.
Richmond, VA, US - Received
- November 18, 1999
- Decision date
- January 18, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DEW – Igg, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
Other 510(k)s with product code DEW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050113 | Tina-Quant Igg GEN.2DEW · Traditional | Roche Diagnostics Corp. | 02/08/2005SE |
| K040434 | Roche Diagnostics Tina-Quant Igg GEN.2DEW · Special | Roche Diagnostics Corp. | 03/10/2004SE |
| K010617 | Spife Ife Calibrator and Control KitDEW · Traditional | Helena Laboratories | 03/15/2001SE |
| K993281 | K-Assay IggDEW · Traditional | Kamiya Biomedical Co. | 11/09/1999SE |
| K983221 | IggDEW · Traditional | Abbott Laboratories | 11/04/1998SE |
| K965108 | Synchron LX Systems Immunoglobulin G/A/M ReagentDEW · Traditional | Beckman Instruments, Inc. | 03/06/1997SE |
| K963974 | Image-Immunochemistry System Urine ImmunoglobulinDEW · Traditional | Beckman Instruments, Inc. | 03/06/1997SE |
| K963868 | Immage Immunochemistry System Immunoglobulin G (Igg), a (Iga) and M (Igm)DEW · Traditional | Beckman Instruments, Inc. | 02/10/1997SE |
| K962202 | Quantex IggDEW · Traditional | Instrumentation Laboratory CO | 09/26/1996SE |
| K955798 | Igg Immunoturbidimetric & CalibratorDEW · Traditional | Randox Laboratories, Ltd. | 04/05/1996SE |
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| 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-Igg Ii-Ha, Immunoglobulin Calibrator Set, Immunolobulin Standard cleared by the FDA?
Wako-Igg Ii-Ha, Immunoglobulin Calibrator Set, Immunolobulin Standard (K993928) received a 510(k) decision of Substantially Equivalent on January 18, 2000, 61 days after the submission was received.
What is the product code of K993928?
The FDA product code is DEW – Igg, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.