IMMUNOCYT
System, Test, (ihc), Tumor Marker, Monitoring, Bladder Cancer
DIAGNOCURE, INC.
The following data is part of a premarket notification filed by Diagnocure, Inc. with the FDA for Immunocyt.
Pre-market Notification Details
| Device ID | K994356 |
| 510k Number | K994356 |
| Device Name: | IMMUNOCYT |
| Classification | System, Test, (ihc), Tumor Marker, Monitoring, Bladder Cancer |
| Applicant | DIAGNOCURE, INC. 815 CONNECTICUT AVE, N.W. SUITE 200 Washington, DC 20006 -4004 |
| Contact | Bruce F Mackler |
| Correspondent | Bruce F Mackler DIAGNOCURE, INC. 815 CONNECTICUT AVE, N.W. SUITE 200 Washington, DC 20006 -4004 |
| Product Code | NBK |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-23 |
| Decision Date | 2000-02-23 |
| Summary: | summary |
Trademark Results [IMMUNOCYT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IMMUNOCYT 75113821 2732356 Dead/Cancelled |
SANOFI PASTEUR LIMITED/SANOFI PASTEUR LIMITEE 1996-06-04 |
 IMMUNOCYT 75113775 2656746 Dead/Cancelled |
SANOFI PASTEUR LIMITED/SANOFI PASTEUR LIMITEE 1996-06-04 |
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