510(k) K994356
- Device
- IMMUNOCYT
- Applicant
- DIAGNOCURE, INC.
- 510(k) number
- K994356
- Product code
- NBK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-02-23
- Date received
- 1999-12-23
- Regulation
- 864.1860
- Classification name
- System, Test, (ihc), Tumor Marker, Monitoring, Bladder Cancer
- Medical specialty
- Hematology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BRUCE F MACKLER
- Address
- 815 Connecticut Ave., NW Suite 200 Washington DC US 20006 20006
Source Documents#
Legacy Summary#
summary
FDA Review#
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