The following data is part of a premarket notification filed by Coulter Immunology with the FDA for Coulter Clone Gam-fitc Poly Anti (igg & Igm).
| Device ID | K893419 |
| 510k Number | K893419 |
| Device Name: | COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM) |
| Classification | Igg, Antigen, Antiserum, Control |
| Applicant | COULTER IMMUNOLOGY 440 COULTER WAY WEST 20TH STREET Hialeah, FL 33010 |
| Contact | Qee C Matthews |
| Correspondent | Qee C Matthews COULTER IMMUNOLOGY 440 COULTER WAY WEST 20TH STREET Hialeah, FL 33010 |
| Product Code | DEW |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-02 |
| Decision Date | 1989-08-03 |