The following data is part of a premarket notification filed by Coulter Immunology with the FDA for Cyto-stat/coulter Clone T4-rd1/t8-fitc Mono Anti.
| Device ID | K895917 |
| 510k Number | K895917 |
| Device Name: | CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI |
| Classification | Counter, Differential Cell |
| Applicant | COULTER IMMUNOLOGY 440 COULTER WAY WEST 20TH STREET Hialeah, FL 33010 |
| Contact | Gregory M Butchko |
| Correspondent | Gregory M Butchko 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 | 1989-10-10 |
| Decision Date | 1989-12-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590541385 | K895917 | 000 |
| 15099590539726 | K895917 | 000 |