IMMUNE CELL FUNCTION ASSAY
FDA 510(k) clearance K013169 · decided 2002-04-02
Clearance details
- K-number
- K013169
- Device name
- IMMUNE CELL FUNCTION ASSAY
- Applicant
- Cylex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-09-21
- Decision date
- 2002-04-02
- Days to decision
- 193 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY (K101911) | Cylex, Inc. | 2010-10-18 |
Recalls involving this device
No recalls on record reference this clearance.