IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY
FDA 510(k) clearance K101911 · decided 2010-10-18
Clearance details
- K-number
- K101911
- Device name
- IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY
- Applicant
- Cylex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-07-09
- Decision date
- 2010-10-18
- Days to decision
- 101 days
- Clearance type
- Special
- Product code
- NID
- Device class
- 2
- Regulation number
- 864.5220
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Baldwin, MD, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| IMMUNE CELL FUNCTION ASSAY (K013169) | Cylex, Inc. | 2002-04-02 |
Recalls involving this device
No recalls on record reference this clearance.