The following data is part of a premarket notification filed by Coulter Immunology with the FDA for Cyto-stat/coulter Clone Cd3(igg1)-fitc/t4-rd1.
| Device ID | K922745 |
| 510k Number | K922745 |
| Device Name: | CYTO-STAT/COULTER CLONE CD3(IGG1)-FITC/T4-RD1 |
| Classification | Counter, Differential Cell |
| Applicant | COULTER IMMUNOLOGY 440 COULTER WAY WEST 20TH STREET Hialeah, FL 33010 |
| Contact | Gaide |
| Correspondent | Gaide COULTER IMMUNOLOGY 440 COULTER WAY WEST 20TH STREET Hialeah, FL 33010 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-08 |
| Decision Date | 1993-02-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590542474 | K922745 | 000 |