Iga Minineph Antiserum
FDA 510(k) K981786 · The Binding Site, Ltd.
510(k) numberK981786
Submission
- Device name
- Iga Minineph Antiserum
- Applicant
- The Binding Site, Ltd.
Santa Monica, CA, US - Received
- May 20, 1998
- Decision date
- November 24, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CFQ – Radioimmunoassay, Immunoglobulins (G, A, M)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
Other 510(k)s with product code CFQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K990552 | Immunoglobulin a Test SystemCFQ · Traditional | Dade Behring, Inc. | 03/25/1999SE |
| K990551 | Igg Flex Reagent CartridgeCFQ · Traditional | Dade Behring, Inc. | 03/25/1999SE |
| K990553 | Igm Flex Reagent CartridgeCFQ · Traditional | Dade Behring, Inc. | 03/22/1999SE |
| K951055 | Olympus Iga Immunoturbidimetric ReagentCFQ · Traditional | Olympus America, Inc. | 04/17/1995SE |
| K951013 | Olympus Igg Immunoturbidimetric ReagentCFQ · Traditional | Olympus America, Inc. | 04/17/1995SE |
| K950900 | Olympus Igm Immunoturbidimetric ReagentCFQ · Traditional | Olympus America, Inc. | 03/27/1995SE |
| K891188 | Titan Gel Ife Trivalent AntiserumCFQ · Traditional | Helena Laboratories | 03/22/1989SE |
| K890561 | Spq(Tm) Antibody Reagent Set II for IgmCFQ · Traditional | Atlantic Antibodies | 02/23/1989SE |
| K881928 | Monoclonal Radial Immunodiffusion KitCFQ · Traditional | The Binding Site, Ltd. | 07/08/1988SE |
| K881827 | Immunoglobulin a Test SystemCFQ · Traditional | The Binding Site, Ltd. | 06/10/1988SE |
More from The Binding Site, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K231290 | Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free KitDFH · Traditional | 01/24/2024SE |
| K140105 | Hevylite Human Iga Kappa Kit for Use on Siemens Bnii, Hevylite Human Iga Lambda Kit for…OPX · Traditional | 03/18/2014SE |
| K132555 | Hevylite Human Igg Kappa Kit and Hevylite Human Igg Lambda KitPCN · Traditional | 12/20/2013SE |
| K103824 | Human Iga Liquid Reagent Kit for Use on SPA PlusCFN · Traditional | 02/27/2012SE |
| K100455 | Spaplus AnalyzerDBI · Traditional | 09/03/2010SE |
| K090920 | Human Igg Subclass Liquid Reagent Kits (for Use on Hitachi 911/ 912/ 917 and Modular P)CFN · Traditional | 12/30/2009SE |
| K092450 | Human Igd Kit for Use on SpaplusCZJ · Traditional | 12/28/2009SE |
| K083289 | Human BETA-2 Microglobulin KitJZG · Traditional | 05/06/2009SE |
| K082129 | Human Igm Liquid Reagent Kit for Use on the Spaplus AnalyzerCFN · Traditional | 02/10/2009SE |
| K081827 | Human Iga Liquid Reagent Kit for Use on SpaplusCFN · Traditional | 12/19/2008SE |
Questions and answers
When was Iga Minineph Antiserum cleared by the FDA?
Iga Minineph Antiserum (K981786) received a 510(k) decision of Substantially Equivalent on November 24, 1999, 553 days after the submission was received.
What is the product code of K981786?
The FDA product code is CFQ – Radioimmunoassay, Immunoglobulins (G, A, M), a Class II (moderate risk) device regulated under 21 CFR 866.5510.