Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls
FDA 510(k) clearance K172868 · decided 2018-02-28
Clearance details
- K-number
- K172868
- Device name
- Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls
- Applicant
- The Binding Site Group , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2017-09-20
- Decision date
- 2018-02-28
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- DCN
- Device class
- 2
- Regulation number
- 866.5270
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Birmingham, GB
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch The Binding Site Group
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent i recall (Z-0671-2020) | The Binding Site Group, Ltd. | 2019-12-12 |