Human CH50 Reagent Pack for Use on the Spaplus, Human CH50 Calibrator Set for Use on the Spaplus, Human CH50 Controls Fo
FDA 510(k) K113349 · The Binding Site Group , Ltd.
510(k) numberK113349
Submission
- Device name
- Human CH50 Reagent Pack for Use on the Spaplus, Human CH50 Calibrator Set for Use on the Spaplus, Human CH50 Controls Fo
- Applicant
- The Binding Site Group , Ltd.
Birmingham, GB - Received
- November 14, 2011
- Decision date
- July 11, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DAE – Complement C9, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5240
- Specialty
- Immunology
Other 510(k)s with product code DAE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K150412 | Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 CalibratorDAE · Traditional | The Binding Site Group , Ltd. | 08/28/2015SE |
| K992488 | Total Haemolytic Complement Rid KitDAE · Traditional | The Binding Site, Ltd. | 09/17/1999SE |
| K974111 | Quidel CH50 Eq EiaDAE · Traditional | Quidel Corp. | 07/29/1998SE |
| K954145 | Wako Autokit CH50DAE · Traditional | Wako Chemicals USA, Inc. | 12/18/1995SE |
| K951639 | Complement Activation Eia Test System (Cae)DAE · Traditional | Incstar Corp. | 10/13/1995SE |
More from Incstar Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K250159 | Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT AnalyserSGG · Traditional | 10/17/2025SE |
| K250549 | Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free KitDFH · Traditional | 05/23/2025SE |
| K192116 | Human IgA liquid reagent kit for Use on SPAPlusCFN · Special | 09/04/2019SE |
| K191985 | Optilite IgA KitCFN · Special | 08/19/2019SE |
| K191635 | Optilite IgM KitCFN · Special | 07/15/2019SE |
| K191465 | Human IgM Kit for use on SPAPlusCFN · Special | 06/27/2019SE |
| K190686 | Optilite IgM CSF KitCFN · Traditional | 05/28/2019SE |
| K183151 | Optilite IgA CSF KitCFN · Traditional | 01/23/2019SE |
| K180099 | Optilite High Sensitivity C-Reactive Protein KitDCN · Traditional | 10/12/2018SE |
| K173732 | Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free KitDFH · Traditional | 08/23/2018SE |
Questions and answers
When was Human CH50 Reagent Pack for Use on the Spaplus, Human CH50 Calibrator Set for Use on the Spaplus, Human CH50 Controls Fo cleared by the FDA?
Human CH50 Reagent Pack for Use on the Spaplus, Human CH50 Calibrator Set for Use on the Spaplus, Human CH50 Controls Fo (K113349) received a 510(k) decision of Substantially Equivalent on July 11, 2012, 240 days after the submission was received.
What is the product code of K113349?
The FDA product code is DAE – Complement C9, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5240.