The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Imagn(tm) 2000 System.
| Device ID | K945756 |
| 510k Number | K945756 |
| Device Name: | IMAGN(TM) 2000 SYSTEM |
| Classification | Counter, Differential Cell |
| Applicant | BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Contact | Laurie A Ridener |
| Correspondent | Laurie A Ridener BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-23 |
| Decision Date | 1995-12-19 |