The following data is part of a premarket notification filed by Coulter Immunology with the FDA for Coulter Clone B1 Monoclonal Antibody.
| Device ID | K882557 |
| 510k Number | K882557 |
| Device Name: | COULTER CLONE B1 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 | 1988-06-21 |
| Decision Date | 1988-09-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590540951 | K882557 | 000 |
| 15099590540838 | K882557 | 000 |
| 15099590540098 | K882557 | 000 |
| 15099590537067 | K882557 | 000 |