The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Coulter Clone T11 Monoclonal Antibody.
| Device ID | K875047 |
| 510k Number | K875047 |
| Device Name: | COULTER CLONE T11 MONOCLONAL ANTIBODY |
| Classification | Counter, Differential Cell |
| Applicant | COULTER ELECTRONICS, INC. 440 WEST 20 ST. Hialeah, FL 33010 |
| Contact | Edward J Cassidy |
| Correspondent | Edward J Cassidy COULTER ELECTRONICS, INC. 440 WEST 20 ST. 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 | 1987-12-08 |
| Decision Date | 1988-03-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590542542 | K875047 | 000 |
| 15099590542351 | K875047 | 000 |
| 15099590540692 | K875047 | 000 |
| 15099590539627 | K875047 | 000 |