The following data is part of a premarket notification filed by Coulter Immunology with the FDA for Cyto-stat/coulter Clone T11-rd1/b1-fitc Mono. Anti.
| Device ID | K884346 |
| 510k Number | K884346 |
| Device Name: | CYTO-STAT/COULTER CLONE T11-RD1/B1-FITC MONO. ANTI |
| Classification | Counter, Differential Cell |
| Applicant | COULTER IMMUNOLOGY 440 COULTER WAY WEST 20TH STREET Hialeah, FL 33010 |
| Contact | Lee C Matthews |
| Correspondent | Lee C Matthews 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 | 1988-10-14 |
| Decision Date | 1988-12-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590540869 | K884346 | 000 |
| 15099590537326 | K884346 | 000 |