Rid Plate Reader
FDA 510(k) K881174 · The Binding Site, Ltd.
510(k) numberK881174
Submission
- Device name
- Rid Plate Reader
- Applicant
- The Binding Site, Ltd.
Los Angeles, CA, US - Received
- March 18, 1988
- Decision date
- June 8, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JZQ – Plates And Equipment, Radial Immunodiffusion
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.4800
- Specialty
- Immunology
Other 510(k)s with product code JZQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K881675 | Immulon 4 Flat Bottom Plates & Removawell StripsJZQ · Traditional | Dynatech Laboratories, Inc. | 04/21/1988SE |
| K831811 | Revolution Radial Immunodiffusion PlateJZQ · Traditional | Calbiochem-Behring Corp. | 07/28/1983SE |
| K792699 | Ouchterlony Agar PlatesJZQ · Traditional | Meridian Diagnostics, Inc. | 01/24/1980SE |
| K790646 | Helena Quiplate SystemJZQ · Traditional | Helena Laboratories | 05/23/1979SE |
| K770548 | Immunoplate III Radio ImmunodiffusionJZQ · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 04/15/1977SE |
| K761311 | Accraassay Rid KitsJZQ · Traditional | Miles Laboratories, Inc. | 12/30/1976SE |
More from Miles Laboratories, Inc.
| 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 Rid Plate Reader cleared by the FDA?
Rid Plate Reader (K881174) received a 510(k) decision of Substantially Equivalent on June 8, 1988, 82 days after the submission was received.
What is the product code of K881174?
The FDA product code is JZQ – Plates And Equipment, Radial Immunodiffusion, a Class I (low risk) device regulated under 21 CFR 866.4800.