Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator
FDA 510(k) K150412 · The Binding Site Group , Ltd.
510(k) numberK150412
Submission
- Device name
- Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator
- Applicant
- The Binding Site Group , Ltd.
Birmingham, GB - Received
- February 18, 2015
- Decision date
- August 28, 2015
- 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 |
|---|---|---|---|
| K113349 | Human CH50 Reagent Pack for Use on the Spaplus, Human CH50 Calibrator Set for Use on the…DAE · Traditional | The Binding Site Group , Ltd. | 07/11/2012SE |
| 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 |
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| 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 Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator cleared by the FDA?
Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator (K150412) received a 510(k) decision of Substantially Equivalent on August 28, 2015, 191 days after the submission was received.
What is the product code of K150412?
The FDA product code is DAE – Complement C9, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5240.