The following data is part of a premarket notification filed by Coulter Immunology with the FDA for Coulter Clone(r) My4 Monoclonal Antibody.
| Device ID | K894179 |
| 510k Number | K894179 |
| Device Name: | COULTER CLONE(R) MY4 MONOCLONAL ANTIBODY |
| 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 | 1989-06-16 |
| Decision Date | 1990-02-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590542320 | K894179 | 000 |
| 15099590542030 | K894179 | 000 |
| 15099590541958 | K894179 | 000 |
| 15099590541941 | K894179 | 000 |