The following data is part of a premarket notification filed by Coulter Immunology with the FDA for Coulter Clone Mo2.
| Device ID | K884605 |
| 510k Number | K884605 |
| Device Name: | COULTER CLONE MO2 |
| 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 | 1988-11-03 |
| Decision Date | 1989-08-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590542863 | K884605 | 000 |
| 15099590541590 | K884605 | 000 |
| 15099590540913 | K884605 | 000 |
| 15099590540906 | K884605 | 000 |
| 15099590540791 | K884605 | 000 |
| 15099590539863 | K884605 | 000 |
| 15099590539757 | K884605 | 000 |
| 15099590537029 | K884605 | 000 |