The following data is part of a premarket notification filed by Coulter Immunology with the FDA for Coulterclone.
| Device ID | K911793 |
| 510k Number | K911793 |
| Device Name: | COULTERCLONE |
| Classification | Counter, Differential Cell |
| Applicant | COULTER IMMUNOLOGY 440 COULTER WAY WEST 20TH STREET Hialeah, FL 33010 |
| Contact | Marion S.gaide,ph.d. |
| Correspondent | Marion S.gaide,ph.d. 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 | 1991-04-22 |
| Decision Date | 1991-07-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590542870 | K911793 | 000 |
| 15099590542603 | K911793 | 000 |
| 15099590542597 | K911793 | 000 |
| 15099590542580 | K911793 | 000 |
| 15099590542535 | K911793 | 000 |
| 15099590542511 | K911793 | 000 |
| 15099590540920 | K911793 | 000 |
| 15099590540685 | K911793 | 000 |
| 15099590539719 | K911793 | 000 |