The following data is part of a premarket notification filed by Coulter Immunology with the FDA for Cyto-stat(r)/coulter Clone(r) T11-rd1/b4-fitc.
| Device ID | K910473 |
| 510k Number | K910473 |
| Device Name: | CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC |
| 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 | 1991-02-04 |
| Decision Date | 1991-10-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590541392 | K910473 | 000 |