Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser
FDA 510(k) clearance K250159 · decided 2025-10-17
Clearance details
- K-number
- K250159
- Device name
- Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser
- Applicant
- The Binding Site Group , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-01-21
- Decision date
- 2025-10-17
- Days to decision
- 269 days
- Clearance type
- Traditional
- Product code
- SGG
- Device class
- 2
- Regulation number
- 866.5510
- 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.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Soft recall (Z-2362-2026) | The Binding Site Group, Ltd. | 2026-06-09 |