IMMUNOCYT
FDA 510(k) clearance K994356 · decided 2000-02-23
Clearance details
- K-number
- K994356
- Device name
- IMMUNOCYT
- Applicant
- Diagnocure, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-12-23
- Decision date
- 2000-02-23
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- NBK
- Device class
- 2
- Regulation number
- 864.1860
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.